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

Infant, Premature, Diseases Clinical Trial

— Ca-P  

Official title:

The Impact of the Dose of Vitamin D (vitD) on the Metabolism of ca, p and Concentrations of 25OHD, Bone Status and Development of Premature Infants up to 2 Years of Age. Prospective, Randomized, Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03691896
• Other study ID #: 501-1-13-15-16
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: Centre of Postgraduate Medical Education
• Contact: Magdalena Zarlenga, MD
• Phone: +48224851171
• Email: magda.cmkp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The participants of the study will be prematures, born ≤32 GA, hospitalized in the Department of Neonatology, in the neonatal intensive care unit. Hospitalized patients who meet the inclusion criteria will be randomized in 3 groups assigned to different doses of vit. D (400, 800 or 1200 units(UNT) of vitamin D).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 32 Weeks

Eligibility

Inclusion Criteria:

• 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.

Exclusion criteria

• 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

Related Conditions & MeSH terms

• Infant, Premature, Diseases
• Premature Birth

Intervention

Dietary Supplement:
• Cholecalciferol 400
dose 400 UNT/day for 12 months
• Cholecalciferol 800
dose 800 UNT/day for 12 months

Drug:
• Cholecalciferol 1200
dose 1200 UNT/day for 12 months

Locations

Country	Name	City	State
Poland	SPSK im. prof. W.Orlowskiego CMKP Neonatology Departament	Warszawa	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

References & Publications (10)

Backström MC, Mäki R, Kuusela AL, Sievänen H, Koivisto AM, Koskinen M, Ikonen RS, Mäki 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Natarajan CK, Sankar MJ, Agarwal R et al. Trial of Daily Vitamin D Supplementation in Preterm Infants. Pediatrics. 2014. http://dx.doi.org/10.1542/peds.2012-3395

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of supplementation of Vit. D during pregnancy on 25OHD serum level in Polish mothers	assessment of 25OH D levels in mothers deficiency: <10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml	day of labour
Secondary	Impact of dosage of Vit D3 (400/800/1200 UNT per day) on serum 25OH D levels in preterm children	assessment of serum 25OH D levels in children deficiency: <10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml; high level > 60ng/ml, toxic level > 100ng/ml	4,8,12 weeks of life,1 and 2 years of age
Secondary	Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on Ca serum levels	assessment of Ca serum levels in children	4,8,12 weeks of life,1 and 2 years of age
Secondary	Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on P serum levels	assessment of P serum levels in children	4,8,12 weeks of life,1 and 2 years of age
Secondary	Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary Ca excretion	assessment of urinary calcium/creatinine index	4,8,12 weeks of life,1 and 2 years of age
Secondary	Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary P excretion	assessment of urinary P/creatinine index (mg/mg)	4,8,12 weeks of life,1 and 2 years of age
Secondary	impact of total annual Vit D3 dose and bone calcification in children	assessment of bone status :Densitometry (DEXA)	average of 1 and 2 years of age
Secondary	correlation of cord blood 25OHD level and GA	birth <24 GA, 24-28GA, 28-32GA	1st day of life
Secondary	impact of cord blood 25OHD level on birth weight	assessment of percentile of birth weight (Fenton 2013) hypotrophy <3p, eutrophy 3-97p, hypertrophy >97p	1st day of life of age