Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA)

NCT03691896 | Unknown Phase 3

• 1 other identifier: 501-1-13-15-16
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

It has not yet been established the optimal dose of vit. D for preterm infants in Poland. It is not known what dose of vit. D will provide the correct concentration of vit. D and the optimal development of the skeleton of the premature. The study will try to determine the optimal supplementation of vitamin D and the supply of Ca and P for normal growth and development of a child born prematurely. In addition, the investigators will evaluate any risk factors for deficiency and excess of vitamin D and the consequences of its deficiency and overdose. Simultaneously the study would make possible the determination of an optimal schedule for controlling the Ca-P levels in the group of the youngest infants born prematurely. In addition, the study will assess the relationship between maternal and newborn vitamin D resources right after birth, and the incidence of vitamin D deficiency in infants born prematurely. Preterm infants will be randomized in 3 groups assigned to different doses of vit. D. The study will investigate the metabolism of calcium, phosphorus, the health of bones and development of the premature babies till the age of 2.

Conditions

Infant, Premature, Diseases

Keywords

premature; osteopenia; Vit. D; LBW (low birth weight); 25OHD

Outcome Measures

Primary Outcomes (1)

• Serum 25OHD levels in cord blood in Polish preterm infants

  assessment of 25OH D levels in children deficiency: \<10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml

  day of labour

Secondary Outcomes (9)

• Impact of supplementation of Vit. D during pregnancy on 25OHD serum level in Polish mothers

  day of labour

• Impact of dosage of Vit D3 (400/800/1200 UNT per day) on serum 25OH D levels in preterm children

  4,8,12 weeks of life,1 and 2 years of age

• Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on Ca serum levels

  4,8,12 weeks of life,1 and 2 years of age

• Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on P serum levels

  4,8,12 weeks of life,1 and 2 years of age

• Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary Ca excretion

  4,8,12 weeks of life,1 and 2 years of age

Study Arms (3)

Lower dose

EXPERIMENTAL

cholecalciferol 400UNT, oral solution

Dietary Supplement: Cholecalciferol 400

Middle dose

ACTIVE COMPARATOR

cholecalciferol 800UNT, oral solution

Dietary Supplement: Cholecalciferol 800

Higher dose

EXPERIMENTAL

cholecalciferol 1200UNT, oral solution,

Drug: Cholecalciferol 1200

Interventions

Cholecalciferol 400 DIETARY_SUPPLEMENT

dose 400 UNT/day for 12 months

Also known as: vit D

Lower dose

Cholecalciferol 800 DIETARY_SUPPLEMENT

dose 800 UNT/day for 12 months

Also known as: vit D

Middle dose

Cholecalciferol 1200 DRUG

dose 1200 UNT/day for 12 months

Also known as: vit D

Higher dose

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• gestational age ≤32 weeks at birth
• hospitalization in the department no later than at the age of 7 days (for infants born outside the center)
• No birth defects or diseases permanently affecting the ability to accept enteral feeding
• Anticipated possibility of continuous monitoring of the course of treatment in hospital until discharge
• Consent of Parents / legal guardians for the participation in the study.

You may not qualify if:

• gestational age\> 32 weeks at birth
• the beginning of hospitalization in the department later than the age of 7 days (for infants born outside the center)
• presence of congenital defects or diseases permanently affecting the ability to accept enteral feeding (e.g.oesophageal atresia, anal atresia, congenital umbilical hernia, gastroschisis, syndromes genetically determined)
• significant interruption (\> 1 week) of the hospitalization in the center
• lack of consent of the Parents / legal guardians to participation in the study

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

SPSK im. prof. W.Orłowskiego CMKP Neonatology Departament

Warsaw, Masovian Voivodeship, 00-416, Poland

RECRUITING

Related Publications (10)

• Bodnar LM, Klebanoff MA, Gernand AD, Platt RW, Parks WT, Catov JM, Simhan HN. Maternal vitamin D status and spontaneous preterm birth by placental histology in the US Collaborative Perinatal Project. Am J Epidemiol. 2014 Jan 15;179(2):168-76. doi: 10.1093/aje/kwt237. Epub 2013 Oct 11.

  PMID: 24124195 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

• Natarajan CK, Sankar MJ, Agarwal R, Pratap OT, Jain V, Gupta N, Gupta AK, Deorari AK, Paul VK, Sreenivas V. Trial of daily vitamin D supplementation in preterm infants. Pediatrics. 2014 Mar;133(3):e628-34. doi: 10.1542/peds.2012-3395. Epub 2014 Feb 10.

  PMID: 24515510 BACKGROUND

• van de Lagemaat M, Rotteveel J, Schaafsma A, van Weissenbruch MM, Lafeber HN. Higher vitamin D intake in preterm infants fed an isocaloric, protein- and mineral-enriched postdischarge formula is associated with increased bone accretion. J Nutr. 2013 Sep;143(9):1439-44. doi: 10.3945/jn.113.178111. Epub 2013 Jul 31.

  PMID: 23902955 BACKGROUND

• Schanler RJ, Burns PA, Abrams SA, Garza C. Bone mineralization outcomes in human milk-fed preterm infants. Pediatr Res. 1992 Jun;31(6):583-6. doi: 10.1203/00006450-199206000-00009.

  PMID: 1635820 BACKGROUND

• Kislal FM, Dilmen U. Effect of different doses of vitamin D on osteocalcin and deoxypyridinoline in preterm infants. Pediatr Int. 2008 Apr;50(2):204-7. doi: 10.1111/j.1442-200X.2008.02553.x.

  PMID: 18353060 BACKGROUND

• Christmann V, de Grauw AM, Visser R, Matthijsse RP, van Goudoever JB, van Heijst AF. Early postnatal calcium and phosphorus metabolism in preterm infants. J Pediatr Gastroenterol Nutr. 2014 Apr;58(4):398-403. doi: 10.1097/MPG.0000000000000251.

  PMID: 24253367 BACKGROUND

• Backstrom MC, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Koskinen M, Ikonen RS, Maki M. The long-term effect of early mineral, vitamin D, and breast milk intake on bone mineral status in 9- to 11-year-old children born prematurely. J Pediatr Gastroenterol Nutr. 1999 Nov;29(5):575-82. doi: 10.1097/00005176-199911000-00019.

  PMID: 10554126 BACKGROUND

• Fewtrell MS, Prentice A, Jones SC, Bishop NJ, Stirling D, Buffenstein R, Lunt M, Cole TJ, Lucas A. Bone mineralization and turnover in preterm infants at 8-12 years of age: the effect of early diet. J Bone Miner Res. 1999 May;14(5):810-20. doi: 10.1359/jbmr.1999.14.5.810.

  PMID: 10320530 BACKGROUND

• McCarthy RA, McKenna MJ, Oyefeso O, Uduma O, Murray BF, Brady JJ, Kilbane MT, Murphy JF, Twomey A, O' Donnell CP, Murphy NP, Molloy EJ. Vitamin D nutritional status in preterm infants and response to supplementation. Br J Nutr. 2013 Jul 14;110(1):156-63. doi: 10.1017/S0007114512004722. Epub 2012 Nov 27.

  PMID: 23182428 BACKGROUND

MeSH Terms

Conditions

Infant, Premature, Diseases; Premature Birth; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Magdalena Zarlenga, MD

  Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa

  PRINCIPAL INVESTIGATOR

• Maria Wilińska, DSc

  Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa

  STUDY CHAIR

• Ewa Głuszczak-Idziakowska, PhD

  Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Zarlenga, MD

CONTACT

+48224851171; magda.cmkp@gmail.com

Maria Wilińska, DSc

CONTACT

+48225841170

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Of Neonatology

Study Record Dates

• First Submitted: June 18, 2016
• First Posted: October 2, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)