Efficacy of Oral Vitamin D Supplementation in Adolescents and Young Adults.

NCT04377386 | Completed DMC

• 4 other identifiers: ECA-SIMBA-III-20206566807638382020-03-71133-052018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses whether oral supplementation with vitamin D contributes to the reduction of body mass index and lipid profile in adolescents and young adults. The intervention group will receive 1000 IU of vitamin D (DV) and the control group 200 IU of DV.

Conditions

Overweight and Obesity; Overweight Adolescents; Vitamin D Deficiency

Keywords

Vitamin D; Obesity; Weight loss; Body composition; Cholesterol; Triglycerides

Outcome Measures

Primary Outcomes (3)

• Change in body mass index between baseline and week 15

  Change in body mass index (BMI) will be made through of the measure of body weight will be in kilograms (kg) to one decimal place, and the size in meters (m) to two decimal places. From these measurements the body mass index will be obtained using the formula: BMI = Weight (kg) / size (m)2.

  Baseline and week 15

• Change in lipid profile (Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides) between baseline and week 15

  Serum is measured from the same blood samples drawn for vitamin D levels. The processing and analysis of the samples will be done respectively through enzymatic technique, selective liquid detergent, selective detergent accelerator and Glycerol Phosphate Oxidase.

  Baseline and week 15

• Change in 25-hydroxyvitamin D [25(OH)D] levels between baseline and week 15

  After a 10-12 hour fast, in peripheral venous blood 25-hydroxyvitamin D \[25(OH)D\] is quantified in serum by chemiluminescent microparticle immunoassay (CMIA).

  baseline and week 15

Secondary Outcomes (3)

• Change in waist - hip ratio between baseline and week 15

  Baseline and week 15

• Change of percentage body fat (PBF) in skin folds between baseline and week 15

  Baseline and week 15

• Change in fasting blood glucose level between baseline and week 15

  Baseline and week 15

Study Arms (2)

Intervention group: 1000 IU DV

EXPERIMENTAL

The 75 participants assigned to the intervention group will take 1 DV capsule of 1000 IU daily for 15 weeks.

Dietary Supplement: 1000 IU D vitamin

Control group: 200 IU DV

PLACEBO COMPARATOR

The 75 participants of the control group will take 1 DV capsule of 200 IU daily for 15 weeks, this dose being the minimum recommended for children. The above, considering that it is ethical for the control group to receive a minimum dose of supplementation.

Dietary Supplement: 200 IU D vitamin

Interventions

1000 IU D vitamin DIETARY_SUPPLEMENT

Participants in the intervention group will receive 105 DV doses of 1000 IU. The supplementation will be given by the Farma de Colombia laboratory, known commercially as Farma D, whose presentation is in soft gelatin capsules. It is recommended to take one dose per day at the same time and participants should record the daily intake time of the supplement for 15 weeks on a calendar.

Also known as: Supplementation with 1000 IU vitamin D, Farma D 1000 IU

Intervention group: 1000 IU DV

200 IU D vitamin DIETARY_SUPPLEMENT

Participants in the control group will receive 105 DV doses of 200 IU. The supplementation will be given by the same laboratory; it will have the same characteristics and recommendations for the intake as for the intervention group.

Also known as: Supplementation with 200 IU vitamin D, Farma D 200 IU

Control group: 200 IU DV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Belonging to the SIMBA cohort.
• Age ≥ 18 years.
• Re-contact consent from previous studies.

You may not qualify if:

• Medical diagnosis of diabetes mellitus, clinically manifest endocrinopathies, acute or chronic infectious liver disease, and kidney disease.
• Adolescents or Young adults subject to treatment with steroids or hormones (except levothyroxine) up to one month before lab sample taking.
• Current supplementation with VD (any form).

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead
• Universidad Industrial de Santander: collaborator
• Farma de Colombia SA: collaborator

Study Sites (1)

Fundación Cardiovascular de Colombia

Floridablanca, Santander Department, 681004, Colombia

Location

Related Publications (12)

• Charoenngam N, Shirvani A, Holick MF. Vitamin D for skeletal and non-skeletal health: What we should know. J Clin Orthop Trauma. 2019 Nov-Dec;10(6):1082-1093. doi: 10.1016/j.jcot.2019.07.004. Epub 2019 Jul 13.

  PMID: 31708633 BACKGROUND

• Al Mheid I, Quyyumi AA. Vitamin D and Cardiovascular Disease: Controversy Unresolved. J Am Coll Cardiol. 2017 Jul 4;70(1):89-100. doi: 10.1016/j.jacc.2017.05.031.

  PMID: 28662812 BACKGROUND

• Gholami F, Moradi G, Zareei B, Rasouli MA, Nikkhoo B, Roshani D, Ghaderi E. The association between circulating 25-hydroxyvitamin D and cardiovascular diseases: a meta-analysis of prospective cohort studies. BMC Cardiovasc Disord. 2019 Nov 7;19(1):248. doi: 10.1186/s12872-019-1236-7.

  PMID: 31699030 BACKGROUND

• Paschou SA, Kosmopoulos M, Nikas IP, Spartalis M, Kassi E, Goulis DG, Lambrinoudaki I, Siasos G. The Impact of Obesity on the Association between Vitamin D Deficiency and Cardiovascular Disease. Nutrients. 2019 Oct 14;11(10):2458. doi: 10.3390/nu11102458.

  PMID: 31615154 BACKGROUND

• Alloubani A, Akhu-Zaheya L, Samara R, Abdulhafiz I, Saleh A, Altowijri A. Relationship between Vitamin D Deficiency, Diabetes, and Obesity. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1457-1461. doi: 10.1016/j.dsx.2019.02.021. Epub 2019 Feb 20.

  PMID: 31336506 BACKGROUND

• Hossain MJ, Levinson A, George D, Canas J, Kumar S, Balagopal PB. Vitamin D Status and Cardiovascular Risk in Obesity: Effect of Physical Activity in Nonvitamin D Supplemented Adolescents. Metab Syndr Relat Disord. 2018 May;16(4):197-203. doi: 10.1089/met.2017.0171. Epub 2018 Mar 13.

  PMID: 29649377 BACKGROUND

• Zakharova I, Klimov L, Kuryaninova V, Nikitina I, Malyavskaya S, Dolbnya S, Kasyanova A, Atanesyan R, Stoyan M, Todieva A, Kostrova G, Lebedev A. Vitamin D Insufficiency in Overweight and Obese Children and Adolescents. Front Endocrinol (Lausanne). 2019 Mar 1;10:103. doi: 10.3389/fendo.2019.00103. eCollection 2019.

  PMID: 30881343 BACKGROUND

• Villa-Roel C, Buitrago A, Rodriguez DC, Cano DJ, Martinez MP, Camacho PA, Ruiz AJ, Duran AE. Prevalence of metabolic syndrome in scholars from Bucaramanga, Colombia: a population-based study. BMC Pediatr. 2009 Apr 21;9:28. doi: 10.1186/1471-2431-9-28.

  PMID: 19383169 BACKGROUND

• Mueller NT, Pereira MA, Buitrago-Lopez A, Rodriguez DC, Duran AE, Ruiz AJ, Rueda-Clausen CF, Villa-Roel C. Adiposity indices in the prediction of insulin resistance in prepubertal Colombian children. Public Health Nutr. 2013 Feb;16(2):248-55. doi: 10.1017/S136898001200393X. Epub 2012 Aug 24.

  PMID: 22916737 BACKGROUND

• Serrano N, Villa-Roel C, Gamboa-Delgado EM, Barrera JG, Quintero-Lesmes DC. Early evaluation of the metabolic syndrome in Bucaramanga, Colombia. Transl Pediatr. 2019 Dec;8(5):363-370. doi: 10.21037/tp.2019.04.04.

  PMID: 31993348 BACKGROUND

• Serrano NC, Rojas LZ, Gamboa-Delgado EM, Suarez DP, Salazar Acosta I, Romero SL, Forero M, Quintero-Lesmes DC. Efficacy of vitamin D supplementation in reducing body mass index and lipid profile in healthy young adults in Colombia: a pilot randomised controlled clinical trial. J Nutr Sci. 2023 Feb 22;12:e29. doi: 10.1017/jns.2022.108. eCollection 2023.

  PMID: 36843975 DERIVED

• Serrano NC, Romero SL, Suarez DP, Rojas LZ, Gamboa-Delgado EM, Forero M, Guio E, Quintero-Lesmes DC. Efficacy of oral Vitamin D supplementation in reducing body mass index and lipid profile in adolescents and young adults in Colombia: A pilot clinical trial protocol nested in the SIMBA cohort. Medicine (Baltimore). 2020 Aug 28;99(35):e21722. doi: 10.1097/MD.0000000000021722.

  PMID: 32871891 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Vitamin D Deficiency; Weight Loss

Interventions

Cholecalciferol; Dietary Supplements; Vitamin D

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Body Weight Changes

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assignment of treatment in real time will be made with the support of a computer program. The procedure will take place by means of a single assignment sequence that determines the assignment code for each participant's treatment. This process allows all participants in the study to be assigned to any of the treatment groups. Supplements will be packaged in individual packages with the total number of doses per participant (105 doses). The coding of the packages will be in charge of the laboratory in charge of providing the supplements, which in turn will send to the designated person at the data center by institutional e-mail, a document with the list of codes and the dose of the supplement. The 1000 IU and 200 IU doses of VD will be provided in white containers and will be identical in terms of physical and organoleptic characteristics, to ensure that both participants and investigators are blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study of a two-arm, triple-blind, parallel randomized controlled clinical trial, in 150 adolescents and young adults in the city of Bucaramanga-Colombia. All participants will be given 105 doses of VD. The 75 participants assigned to the intervention group will take one 1000 IU VD capsule daily for 15 weeks. On the other hand, the 75 participants in the control group will take 1 capsule of VD of 200 IU for the same time. The participants in both the intervention and the control group must record in a calendar the time of the daily intake of the supplement during the 15 weeks. The main outcomes are: serum levels of 25 (OH) D, body mass index and lipid profile; Secondary measures complement the previous ones (skin folds, waist-to-hip ratio). Other variables will be analyzed such as: assessment of dietary intake, physical activity, sun exposure, cigarette and tobacco consumption and adherence to supplementation with DV.

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: May 6, 2020
• Study Start: August 3, 2020
• Primary Completion: November 2, 2020
• Study Completion: February 2, 2021
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)