Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA)
NCT ID: NCT03691896
Last Updated: 2018-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2016-01-31
2019-12-31
Brief Summary
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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.
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Detailed Description
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At defined age points of postnatal life, parameters of calcium and phosphorus metabolism and vitamin D level will be tested, along with the health of bones, health status and development.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
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Lower dose
cholecalciferol 400UNT, oral solution
Cholecalciferol 400
dose 400 UNT/day for 12 months
Middle dose
cholecalciferol 800UNT, oral solution
Cholecalciferol 800
dose 800 UNT/day for 12 months
Higher dose
cholecalciferol 1200UNT, oral solution,
Cholecalciferol 1200
dose 1200 UNT/day for 12 months
Interventions
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Cholecalciferol 400
dose 400 UNT/day for 12 months
Cholecalciferol 800
dose 800 UNT/day for 12 months
Cholecalciferol 1200
dose 1200 UNT/day for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
24 Weeks
32 Weeks
ALL
No
Sponsors
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Centre of Postgraduate Medical Education
OTHER
Responsible Party
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Maria Wilinska
Head Of Neonatology
Principal Investigators
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Magdalena Zarlenga, MD
Role: PRINCIPAL_INVESTIGATOR
Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa
Maria Wilińska, DSc
Role: STUDY_CHAIR
Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa
Ewa Głuszczak-Idziakowska, PhD
Role: PRINCIPAL_INVESTIGATOR
Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa
Locations
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SPSK im. prof. W.Orłowskiego CMKP Neonatology Departament
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Maria Wilińska, DSc
Role: CONTACT
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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501-1-13-15-16
Identifier Type: -
Identifier Source: org_study_id
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