Monitored vs Standard Supplementation of Vitamin D in Preterm Infants

NCT03087149 | Completed DMC

• 1 other identifier: VitD-2016
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is safer and more effective than standard therapy in pretrem infants.

Conditions

Vitamin D Deficiency; Osteopenia; Nephrolithiasis; Drug Overdose

Keywords

vitamin D; supplementation; hydroxyvitamin D; pretrem infants; osteopenia

Outcome Measures

Primary Outcomes (4)

• Number of Participants with D- deficiency or access

  25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )

  at 40 (+/-2 weeks) PMA (postmenstrual age)

• Number of Participants with D- deficiency or access

  25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )

  at 4 weeks of age

• Number of Participants with D- deficiency or access

  25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )

  At 35 (+/-2 weeks) PMA (postmenstrual age)

• Number of Participants with D- deficiency or access

  25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )

  At 52 (+/-2 weeks) PMA (postmenstrual age)

Secondary Outcomes (5)

• Number of Participants with biochemical markers of osteopenia

  at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

• average of bone mass

  at 35, 40 (+/-2 weeks) PMA

• Number of Participants with hypercalcemia

  at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

• Number of Participants with hypercalcuria

  at 35, 40, 52 (+/-2 weeks) PMA

• Number of Participants with nephrocalcinosis

  at 35, 52 (+/-2 weeks) PMA

Other Outcomes (3)

• Number of Participants with vitamin D- acceptable range

  at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

• Number of Participants with vitamin D- optimal range

  at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

• Avarage of vitamin D level

  at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

Study Arms (2)

monitored group

EXPERIMENTAL

The monitored group will received monitored vit D supplementation

Dietary Supplement: monitored vit D supplementation

standard group

ACTIVE COMPARATOR

The standard group will receive standard vit D supplementation

Dietary Supplement: standard vit D supplementation

Interventions

monitored vit D supplementation DIETARY_SUPPLEMENT

The vit D supplementation dose start from dose 500IU from 7th day of age and is modified based on vit D measurement at 4 week of age for infants born \<30 GA, at 8 week of age for infants born \<26 GA at 35+/-2 weeks PMA(postmenstrual age), +/-at 40+/-2 weeks PMA according to the protocol.

monitored group

standard vit D supplementation DIETARY_SUPPLEMENT

The vitamin D supplementation dose is 500IU from 7th day of age.

standard group

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound)
• In born or admitted to the unit within 48hours from birth.
• Randomization within 7 days from birth.
• Parental consent.
• Mothers willing to return for follow up visits.

You may not qualify if:

• Preterm delivery \>=33 weeks of gestation or term delivery (estimated by ultrasound).
• Major congenital abnormalities.
• Participation in another trial.
• Severe illness at birth deemed incompatible with survival.
• Congenital HIV infection.
• Total parenteral nutrition \> 14 days.
• Cholestasis

Sponsors & Collaborators

• Princess Anna Mazowiecka Hospital, Warsaw, Poland: lead
• Medical University of Warsaw: collaborator

Study Sites (1)

Princess Anna Mazowiecka Hospital

Warsaw, 00-315, Poland

Location

Related Publications (25)

• Backstrom MC, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Kouri T, Maki M. Randomised controlled trial of vitamin D supplementation on bone density and biochemical indices in preterm infants. Arch Dis Child Fetal Neonatal Ed. 1999 May;80(3):F161-6. doi: 10.1136/fn.80.3.f161.

  PMID: 10212074 BACKGROUND

• Rigo J, Pieltain C, Salle B, Senterre J. Enteral calcium, phosphate and vitamin D requirements and bone mineralization in preterm infants. Acta Paediatr. 2007 Jul;96(7):969-74. doi: 10.1111/j.1651-2227.2007.00336.x.

  PMID: 17577338 BACKGROUND

• Zerofsky M, Ryder M, Bhatia S, Stephensen CB, King J, Fung EB. Effects of early vitamin D deficiency rickets on bone and dental health, growth and immunity. Matern Child Nutr. 2016 Oct;12(4):898-907. doi: 10.1111/mcn.12187. Epub 2015 Apr 7.

  PMID: 25850574 BACKGROUND

• Zhu K, Whitehouse AJ, Hart PH, Kusel M, Mountain J, Lye S, Pennell C, Walsh JP. Maternal vitamin D status during pregnancy and bone mass in offspring at 20 years of age: a prospective cohort study. J Bone Miner Res. 2014;29(5):1088-95. doi: 10.1002/jbmr.2138.

  PMID: 24189972 BACKGROUND

• Dinlen N, Zenciroglu A, Beken S, Dursun A, Dilli D, Okumus N. Association of vitamin D deficiency with acute lower respiratory tract infections in newborns. J Matern Fetal Neonatal Med. 2016 Mar;29(6):928-32. doi: 10.3109/14767058.2015.1023710. Epub 2015 Mar 19.

  PMID: 25786473 BACKGROUND

• Grant CC, Kaur S, Waymouth E, Mitchell EA, Scragg R, Ekeroma A, Stewart A, Crane J, Trenholme A, Camargo CA Jr. Reduced primary care respiratory infection visits following pregnancy and infancy vitamin D supplementation: a randomised controlled trial. Acta Paediatr. 2015 Apr;104(4):396-404. doi: 10.1111/apa.12819. Epub 2014 Oct 21.

  PMID: 25283480 BACKGROUND

• Gernand AD, Simhan HN, Caritis S, Bodnar LM. Maternal vitamin D status and small-for-gestational-age offspring in women at high risk for preeclampsia. Obstet Gynecol. 2014 Jan;123(1):40-48. doi: 10.1097/AOG.0000000000000049.

  PMID: 24463662 BACKGROUND

• Whitehouse AJ, Holt BJ, Serralha M, Holt PG, Kusel MM, Hart PH. Maternal serum vitamin D levels during pregnancy and offspring neurocognitive development. Pediatrics. 2012 Mar;129(3):485-93. doi: 10.1542/peds.2011-2644. Epub 2012 Feb 13.

  PMID: 22331333 BACKGROUND

• Pludowski P, Holick MF, Pilz S, Wagner CL, Hollis BW, Grant WB, Shoenfeld Y, Lerchbaum E, Llewellyn DJ, Kienreich K, Soni M. Vitamin D effects on musculoskeletal health, immunity, autoimmunity, cardiovascular disease, cancer, fertility, pregnancy, dementia and mortality-a review of recent evidence. Autoimmun Rev. 2013 Aug;12(10):976-89. doi: 10.1016/j.autrev.2013.02.004. Epub 2013 Mar 28.

  PMID: 23542507 BACKGROUND

• Vogiatzi MG, Jacobson-Dickman E, DeBoer MD; Drugs, and Therapeutics Committee of The Pediatric Endocrine Society. Vitamin D supplementation and risk of toxicity in pediatrics: a review of current literature. J Clin Endocrinol Metab. 2014 Apr;99(4):1132-41. doi: 10.1210/jc.2013-3655. Epub 2014 Jan 23.

  PMID: 24456284 BACKGROUND

• Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1.

  PMID: 16399151 BACKGROUND

• Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463. Erratum In: J Bone Miner Res. 2011 Dec; 26(12):3001.

  PMID: 21706518 BACKGROUND

• Whitehouse AJ, Holt BJ, Serralha M, Holt PG, Hart PH, Kusel MM. Maternal vitamin D levels and the autism phenotype among offspring. J Autism Dev Disord. 2013 Jul;43(7):1495-504. doi: 10.1007/s10803-012-1676-8.

  PMID: 23070790 BACKGROUND

• Cetinkaya M, Cekmez F, Erener-Ercan T, Buyukkale G, Demirhan A, Aydemir G, Aydin FN. Maternal/neonatal vitamin D deficiency: a risk factor for bronchopulmonary dysplasia in preterms? J Perinatol. 2015 Oct;35(10):813-7. doi: 10.1038/jp.2015.88. Epub 2015 Jul 30.

  PMID: 26226242 BACKGROUND

• Cizmeci MN, Kanburoglu MK, Akelma AZ, Ayyildiz A, Kutukoglu I, Malli DD, Tatli MM. Cord-blood 25-hydroxyvitamin D levels and risk of early-onset neonatal sepsis: a case-control study from a tertiary care center in Turkey. Eur J Pediatr. 2015 Jun;174(6):809-15. doi: 10.1007/s00431-014-2469-1. Epub 2014 Dec 12.

  PMID: 25504199 BACKGROUND

• Abrams SA; Committee on Nutrition. Calcium and vitamin d requirements of enterally fed preterm infants. Pediatrics. 2013 May;131(5):e1676-83. doi: 10.1542/peds.2013-0420. Epub 2013 Apr 29.

  PMID: 23629620 BACKGROUND

• Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.

  PMID: 19881390 BACKGROUND

• Pludowski P, Karczmarewicz E, Bayer M, Carter G, Chlebna-Sokol D, Czech-Kowalska J, Debski R, Decsi T, Dobrzanska A, Franek E, Gluszko P, Grant WB, Holick MF, Yankovskaya L, Konstantynowicz J, Ksiazyk JB, Ksiezopolska-Orlowska K, Lewinski A, Litwin M, Lohner S, Lorenc RS, Lukaszkiewicz J, Marcinowska-Suchowierska E, Milewicz A, Misiorowski W, Nowicki M, Povoroznyuk V, Rozentryt P, Rudenka E, Shoenfeld Y, Socha P, Solnica B, Szalecki M, Talalaj M, Varbiro S, Zmijewski MA. Practical guidelines for the supplementation of vitamin D and the treatment of deficits in Central Europe - recommended vitamin D intakes in the general population and groups at risk of vitamin D deficiency. Endokrynol Pol. 2013;64(4):319-27. doi: 10.5603/ep.2013.0012.

  PMID: 24002961 BACKGROUND

• Monangi N, Slaughter JL, Dawodu A, Smith C, Akinbi HT. Vitamin D status of early preterm infants and the effects of vitamin D intake during hospital stay. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F166-8. doi: 10.1136/archdischild-2013-303999. Epub 2013 Jul 13.

  PMID: 23852093 BACKGROUND

• Pinto K, Collins CT, Gibson RA, Andersen CC. Vitamin D in preterm infants: A prospective observational study. J Paediatr Child Health. 2015 Jul;51(7):679-81. doi: 10.1111/jpc.12847. Epub 2015 Feb 12.

  PMID: 25683497 BACKGROUND

• Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.

  PMID: 27079965 BACKGROUND

• Backstrom MC, Kouri T, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Maki M. Bone isoenzyme of serum alkaline phosphatase and serum inorganic phosphate in metabolic bone disease of prematurity. Acta Paediatr. 2000 Jul;89(7):867-73.

  PMID: 10943972 BACKGROUND

• Nemet D, Dolfin T, Wolach B, Eliakim A. Quantitative ultrasound measurements of bone speed of sound in premature infants. Eur J Pediatr. 2001 Dec;160(12):736-40. doi: 10.1007/s004310100849.

  PMID: 11795683 BACKGROUND

• Rack B, Lochmuller EM, Janni W, Lipowsky G, Engelsberger I, Friese K, Kuster H. Ultrasound for the assessment of bone quality in preterm and term infants. J Perinatol. 2012 Mar;32(3):218-26. doi: 10.1038/jp.2011.82. Epub 2011 Jun 16.

  PMID: 21681177 BACKGROUND

• Kolodziejczyk A, Borszewska-Kornacka MK, Seliga-Siwecka J. MOnitored supplementation of VItamin D in preterm infants (MOSVID trial): study protocol for a randomised controlled trial. Trials. 2017 Sep 11;18(1):424. doi: 10.1186/s13063-017-2141-y.

  PMID: 28893306 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Vitamin D Deficiency; Bone Diseases, Metabolic; Nephrolithiasis; Drug Overdose

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Maria K Borszewska-Kornacka, Professor

  Princess Anna Mazowiecka Hospital

  STUDY CHAIR

• Renata Bokiniec, M.D.

  Princess Anna Mazowiecka Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 22, 2017
• Study Start: May 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)