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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower dose | Experimental | cholecalciferol 400UNT, oral solution |
|
| Middle dose | Active Comparator | cholecalciferol 800UNT, oral solution |
|
| Higher dose | Experimental | cholecalciferol 1200UNT, oral solution, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol 400 | Dietary Supplement | dose 400 UNT/day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Impact of dosage of Vit D3 (400/800/1200 UNT per day) on serum 25OH D levels in preterm children |
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Inclusion Criteria:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magdalena Zarlenga, MD | Contact | +48224851171 | magda.cmkp@gmail.com | |
| Maria Wilińska, DSc | Contact | +48225841170 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPSK im. prof. W.Orłowskiego CMKP Neonatology Departament | Recruiting | Warsaw | Masovian Voivodeship | 00-416 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24124195 | Background | 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. | |
| 23852093 | Background |
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| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| D047928 | Premature Birth |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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| Cholecalciferol 800 | Dietary Supplement | dose 800 UNT/day for 12 months |
|
|
| Cholecalciferol 1200 | Drug | dose 1200 UNT/day for 12 months |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| correlation of cord blood 25OHD level and GA | birth <24 GA, 24-28GA, 28-32GA | 1st day of life |
| 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 |
| Ewa Głuszczak-Idziakowska, PhD |
| Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa |
| Principal Investigator |
| 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. |
| 24515510 | 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. |
| 23902955 | 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. |
| 1635820 | 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. |
| 18353060 | 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. |
| 24253367 | 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. |
| 10554126 | 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. |
| 10320530 | 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. |
| 23182428 | 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. |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |