Adjuvant Effects of Vitamin A and Vitamin D Supplementation on Treatment of Children With ADHD

NCT04284059 | Unknown Phase 4

• 1 other identifier: CHENLI
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 3

Brief Summary

Around 7.2% of children around the world are suffering from ADHD. On account of current medical treatment, a high remission rate can be reached for ADHD. Nevertheless, patients have to face a number of side effects associated with the treatment. It was informed that patients of ADHD have a tendency to vitamin A and vitamin D deficiency. The aim of the study is to determine the effect of vitamin A and vitamin D supplementation as adjunctive therapy to methylphenidate on symptoms of ADHD. 504 subjects aged 6-12 years with a diagnosis of ADHD based on DSM-5 criteria are randomly assigned into three groups to receive vitamin A 6000 IU/day and vitamin D 2100 IU/day, or vitamin D 2100 IU/day or placebo adding to methylphenidate for 8 weeks. Symptoms severity is assessed by Vanderbilt Assessment Scales and Questionnaire - Children with Difficulties at weeks 0, 4, and 8. Serum levels of retinol and 25(OH)D are measured at baseline and after 8 weeks. All the other sociodemographic data are assessed. The study can give more references on the application of vitamin A and vitamin D in addition to methylphenidate to ADHD. Future research is needed to clarify mechanism of vitamin A and vitamin D on ADHD.

Conditions

ADHD

Keywords

Vitamin A; Vitamin D; Methylphenidate; ADHD

Outcome Measures

Primary Outcomes (13)

• The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent assessment scale

  The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.

  at baseline

• The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher assessment scale

  The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.

  at baseline

• The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent assessment scale

  The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.

  at baseline

• The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher assessment scale

  The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.

  at baseline

• The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent assessment scale

  The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.

  at baseline

• The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher assessment scale

  The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.

  at baseline

• The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment

  The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.

  at weeks 4 and 8

• The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment

  The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.

  at weeks 4 and 8

• The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment

  The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.

  at weeks 4 and 8

• The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment

  The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.

  at weeks 4 and 8

• The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent follow-up assessment

  The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.

  at weeks 4 and 8

• The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher follow-up assessment

  The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.

  at weeks 4 and 8

• The changes in ADHD clinical symptoms

  The Questionnaire - Children with Difficulties (QCD) measures the daily-life problems in children aged 6-18 years during the special time of the day, including in the morning, during school, after school, in the evening, and overall difficulties over the entire day and night. It has been proved the Chinese version of QCD has good validity and reliability. Filled in by the parents, the scale consists of 20 questions with regard to ADHD-related difficulties. Each question is scored on a four-point scale: 0 = completely disagree, 1 = somewhat (partially) agree, 2 = mostly agree, and 3 = completely agree. Score of 30 - 35 is considered as cut-off value for functional impairment and score of less than 30 is considered as functional impairment (Full marks: 57). The lower scores indicate lower life functioning and more difficulty in children's daily activities.

  at baseline, weeks 4 and 8

Secondary Outcomes (2)

• Serum concentration of vitamin A.

  at baseline and weeks 8

• Serum concentration of vitamin D.

  at baseline and weeks 8

Study Arms (3)

vitamin AD group

ACTIVE COMPARATOR

The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin A 6000 IU/day and vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks.

Dietary Supplement: vitamin AD

vitamin D group

EXPERIMENTAL

The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks. After the study, vitamin D group will be administrated with vitamin A on the basis of serum retinol concentration after the study.

Dietary Supplement: vitamin D

placebo group

PLACEBO COMPARATOR

The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive placebo once a day in addition to methylphenidate for 8 weeks. After the study, the placebo group will be prescribed with vitamin A and vitamin D supplementation on the grounds of retinol and 25 (OH)D concentration.

Drug: Placebos

Interventions

Placebos DRUG

Placebo, vitamin AD and vitamin D are identical in the appearance to guarantee blind. The patients need to administrate 3 capsules once a day for 8 weeks.

placebo group

vitamin AD DIETARY_SUPPLEMENT

A vitamin AD capsule contains vitamin A 2000 IU and vitamin D 700 IU. The patients need to administrate 3 capsules once a day for 8 weeks.

vitamin AD group

vitamin D DIETARY_SUPPLEMENT

A vitamin D capsule contains vitamin D 400 IU. The patients need to asministrate 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks.

vitamin D group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnose of ADHD according to DSM-5
• Aged 6-12 years
• Intelligence quotient (IQ) ≥70
• Receiving methylphenidate (trade name Concerta) 18-54 mg/day once a day (began with 18 mg/day for a week and titrated gradually to the optimum dose not more than 54 mg/day).

You may not qualify if:

• Inconsistent or changing dose of methylphenidate during the participation period
• Use of anticonvulsant drugs or hydrocortisone
• Suffering from other neurological disorders and mental diseases now or in the past, such as convulsions, anxiety and depression
• Suffer from metabolic disorders such as cholestasis, liver dysfunction, pancreatic insufficiency, measles, diarrhea, respiratory illness, severe inflammation or malnutrition, etc.
• Use of vitamins and vitamin-containing products
• IQ≤70
• The serum concentration of vitamin A \>1.05 umol/L and/ or vitamin D \>50 nmol/L

Sponsors & Collaborators

• Chen Li: lead

Study Sites (3)

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

the First Hospital of Jilin University

Changchun, Jilin, 130012, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandonng, 250012, China

NOT YET RECRUITING

Related Publications (23)

• Dehbokri N, Noorazar G, Ghaffari A, Mehdizadeh G, Sarbakhsh P, Ghaffary S. Effect of vitamin D treatment in children with attention-deficit hyperactivity disorder. World J Pediatr. 2019 Feb;15(1):78-84. doi: 10.1007/s12519-018-0209-8. Epub 2018 Nov 19.

  PMID: 30456564 BACKGROUND

• Elshorbagy HH, Barseem NF, Abdelghani WE, Suliman HAI, Al-Shokary AH, Abdulsamea SE, Elsadek AE, Abdel Maksoud YH, Nour El Din DMAE. Impact of Vitamin D Supplementation on Attention-Deficit Hyperactivity Disorder in Children. Ann Pharmacother. 2018 Jul;52(7):623-631. doi: 10.1177/1060028018759471. Epub 2018 Feb 18.

  PMID: 29457493 BACKGROUND

• Evans E, Piccio L, Cross AH. Use of Vitamins and Dietary Supplements by Patients With Multiple Sclerosis: A Review. JAMA Neurol. 2018 Aug 1;75(8):1013-1021. doi: 10.1001/jamaneurol.2018.0611.

  PMID: 29710293 BACKGROUND

• Faraone SV. The pharmacology of amphetamine and methylphenidate: Relevance to the neurobiology of attention-deficit/hyperactivity disorder and other psychiatric comorbidities. Neurosci Biobehav Rev. 2018 Apr;87:255-270. doi: 10.1016/j.neubiorev.2018.02.001. Epub 2018 Feb 8.

  PMID: 29428394 BACKGROUND

• Fasihpour B, Moayeri H, Shariat M, Keihanidoust Z, Effatpanah M, Khedmat L. Vitamin D deficiency in school-age Iranian children with attention-deficit/hyperactivity disorder (ADHD) symptoms: A critical comparison with healthy controls. Child Neuropsychol. 2020 May;26(4):460-474. doi: 10.1080/09297049.2019.1665638. Epub 2019 Sep 13.

  PMID: 31514566 BACKGROUND

• Fragoso YD, Stoney PN, McCaffery PJ. The evidence for a beneficial role of vitamin A in multiple sclerosis. CNS Drugs. 2014 Apr;28(4):291-9. doi: 10.1007/s40263-014-0148-4.

  PMID: 24557746 BACKGROUND

• Gallo EF, Posner J. Moving towards causality in attention-deficit hyperactivity disorder: overview of neural and genetic mechanisms. Lancet Psychiatry. 2016 Jun;3(6):555-67. doi: 10.1016/S2215-0366(16)00096-1. Epub 2016 May 13.

  PMID: 27183902 BACKGROUND

• Hinshaw SP. Attention Deficit Hyperactivity Disorder (ADHD): Controversy, Developmental Mechanisms, and Multiple Levels of Analysis. Annu Rev Clin Psychol. 2018 May 7;14:291-316. doi: 10.1146/annurev-clinpsy-050817-084917. Epub 2017 Dec 8.

  PMID: 29220204 BACKGROUND

• Lopes FM, da Motta LL, De Bastiani MA, Pfaffenseller B, Aguiar BW, de Souza LF, Zanatta G, Vargas DM, Schonhofen P, Londero GF, de Medeiros LM, Freire VN, Dafre AL, Castro MA, Parsons RB, Klamt F. RA Differentiation Enhances Dopaminergic Features, Changes Redox Parameters, and Increases Dopamine Transporter Dependency in 6-Hydroxydopamine-Induced Neurotoxicity in SH-SY5Y Cells. Neurotox Res. 2017 May;31(4):545-559. doi: 10.1007/s12640-016-9699-0. Epub 2017 Feb 2.

  PMID: 28155214 BACKGROUND

• McCaffery P, Drager UC. High levels of a retinoic acid-generating dehydrogenase in the meso-telencephalic dopamine system. Proc Natl Acad Sci U S A. 1994 Aug 2;91(16):7772-6. doi: 10.1073/pnas.91.16.7772.

  PMID: 8052659 BACKGROUND

• Mohammadpour N, Jazayeri S, Tehrani-Doost M, Djalali M, Hosseini M, Effatpanah M, Davari-Ashtiani R, Karami E. Effect of vitamin D supplementation as adjunctive therapy to methylphenidate on ADHD symptoms: A randomized, double blind, placebo-controlled trial. Nutr Neurosci. 2018 Apr;21(3):202-209. doi: 10.1080/1028415X.2016.1262097. Epub 2016 Dec 7.

  PMID: 27924679 BACKGROUND

• Moretti R, Morelli ME, Caruso P. Vitamin D in Neurological Diseases: A Rationale for a Pathogenic Impact. Int J Mol Sci. 2018 Jul 31;19(8):2245. doi: 10.3390/ijms19082245.

  PMID: 30065237 BACKGROUND

• Ono K, Yamada M. Vitamin A and Alzheimer's disease. Geriatr Gerontol Int. 2012 Apr;12(2):180-8. doi: 10.1111/j.1447-0594.2011.00786.x. Epub 2011 Dec 23.

  PMID: 22221326 BACKGROUND

• Palacios C, Gonzalez L. Is vitamin D deficiency a major global public health problem? J Steroid Biochem Mol Biol. 2014 Oct;144 Pt A:138-45. doi: 10.1016/j.jsbmb.2013.11.003. Epub 2013 Nov 12.

  PMID: 24239505 BACKGROUND

• Pertile RA, Cui X, Eyles DW. Vitamin D signaling and the differentiation of developing dopamine systems. Neuroscience. 2016 Oct 1;333:193-203. doi: 10.1016/j.neuroscience.2016.07.020. Epub 2016 Jul 20.

  PMID: 27450565 BACKGROUND

• Pertile RAN, Cui X, Hammond L, Eyles DW. Vitamin D regulation of GDNF/Ret signaling in dopaminergic neurons. FASEB J. 2018 Feb;32(2):819-828. doi: 10.1096/fj.201700713R. Epub 2018 Jan 4.

  PMID: 29018141 BACKGROUND

• Russell VA. Overview of animal models of attention deficit hyperactivity disorder (ADHD). Curr Protoc Neurosci. 2011 Jan;Chapter 9:Unit9.35. doi: 10.1002/0471142301.ns0935s54.

  PMID: 21207367 BACKGROUND

• Seyedi M, Gholami F, Samadi M, Djalali M, Effatpanah M, Yekaninejad MS, Hashemi R, Abdolahi M, Chamari M, Honarvar NM. The Effect of Vitamin D3 Supplementation on Serum BDNF, Dopamine, and Serotonin in Children with Attention-Deficit/Hyperactivity Disorder. CNS Neurol Disord Drug Targets. 2019;18(6):496-501. doi: 10.2174/1871527318666190703103709.

  PMID: 31269890 BACKGROUND

• Song P, Wang J, Wei W, Chang X, Wang M, An L. The Prevalence of Vitamin A Deficiency in Chinese Children: A Systematic Review and Bayesian Meta-Analysis. Nutrients. 2017 Nov 25;9(12):1285. doi: 10.3390/nu9121285.

  PMID: 29186832 BACKGROUND

• Duric NS, Assmus J, Gundersen D, Duric Golos A, Elgen IB. Multimodal treatment in children and adolescents with attention-deficit/hyperactivity disorder: a 6-month follow-up. Nord J Psychiatry. 2017 Jul;71(5):386-394. doi: 10.1080/08039488.2017.1305446. Epub 2017 Mar 27.

  PMID: 28345387 BACKGROUND

• Biederman J, Faraone SV. Attention-deficit hyperactivity disorder. Lancet. 2005 Jul 16-22;366(9481):237-48. doi: 10.1016/S0140-6736(05)66915-2.

  PMID: 16023516 BACKGROUND

• Wolraich ML, Hagan JF Jr, Allan C, Chan E, Davison D, Earls M, Evans SW, Flinn SK, Froehlich T, Frost J, Holbrook JR, Lehmann CU, Lessin HR, Okechukwu K, Pierce KL, Winner JD, Zurhellen W; SUBCOMMITTEE ON CHILDREN AND ADOLESCENTS WITH ATTENTION-DEFICIT/HYPERACTIVE DISORDER. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019 Oct;144(4):e20192528. doi: 10.1542/peds.2019-2528.

  PMID: 31570648 BACKGROUND

• Zhou P, Wolraich ML, Cao AH, Jia FY, Liu B, Zhu L, Liu Y, Li X, Li C, Peng B, Yang T, Chen J, Cheng Q, Li T, Chen L. Adjuvant effects of vitamin A and vitamin D supplementation on treatment of children with attention-deficit/hyperactivity disorder: a study protocol for a randomised, double-blinded, placebo-controlled, multicentric trial in China. BMJ Open. 2021 Jun 16;11(6):e050541. doi: 10.1136/bmjopen-2021-050541.

  PMID: 34135055 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Li Chen, doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

• yu T Li, MS

  Children's Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Li Chen, doctor

CONTACT

136 7762 0103; chenli2012@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participants and care providers don't know which group they are enrolled in. And the investigators just play a roll in recruiting the patients, inform the patients about the study, and then randomly assign the patients in a 1:1:1 ratio to the A group, B group or C group. The drugs are dispensed by staff who was not involved in the process of evaluation, diagnosis and treatment. The staff will take notes about the patients' basic information and medication records. After the study, the staff will give the unblinded results to to investigators and outcomes assessor. The investigators will provide the compensatory therapy for the patients. The outcomes assessor will do the statistic analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor，Director

Model Details: The patients showed deficiency or insufficiency in vitamin A (≤1.05 umol/ L) and vitamin D (≤50 nmol/L) are randomly assigned in double-blind fashion in a 1:1:1 ratio to the vitamin AD supplementation group, vitamin D supplementation group or the placebo group. Vitamin AD supplementation group will be administrated vitamin AD capsules (3 capsules/time, once a day for 8 weeks), which contain vitamin A (2000 IU/capsule) and vitamin D (700 IU/capsule). Vitamin D supplementation group will be administrated vitamin D capsules (400 IU/capsule, 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks). The placebo capsules given to the placebo group (3 capsules/time, once a day for 8 weeks), consists of oily liquids which do not contain vitamin A and vitamin D, and were produced in strict accordance with China's drug management and packaging requirements for placebo by Shandong DYNE Marine Biopharmaceutical Co., Ltd in China.

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 25, 2020
• Study Start: February 25, 2021
• Primary Completion: May 30, 2022
• Study Completion: August 30, 2022
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)