drugset / Trial / NCT00610688
Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Phase 3
Completed
192 enrolled
Children's Hospital Medical Center, Cincinnati
Thrasher Research Fund · collabUnited Arab Emirates University · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.
Timeline
- Start
- 2008-01
- Primary completion
- 2011-06
- Completion
- 2012-04
Publications
- Background Dawodu A, Agarwal M, Sankarankutty M, Hardy D, Kochiyil J, Badrinath P. Higher prevalence of vitamin D deficiency in mothers of rachitic than nonrachitic children. J Pediatr. 2005 Jul;147(1):109-11. doi: 10.1016/j.jpeds.2005.03.001.
- Background Dawodu A, Agarwal M, Hossain M, Kochiyil J, Zayed R. Hypovitaminosis D and vitamin D deficiency in exclusively breast-feeding infants and their mothers in summer: a justification for vitamin D supplementation of breast-feeding infants. J Pediatr. 2003 Feb;142(2):169-73. doi: 10.1067/mpd.2003.63.
- Background Saadi HF, Dawodu A, Afandi BO, Zayed R, Benedict S, Nagelkerke N. Efficacy of daily and monthly high-dose calciferol in vitamin D-deficient nulliparous and lactating women. Am J Clin Nutr. 2007 Jun;85(6):1565-71. doi: 10.1093/ajcn/85.6.1565.
- Background Dawodu A, Wagner CL. Mother-child vitamin D deficiency: an international perspective. Arch Dis Child. 2007 Sep;92(9):737-40. doi: 10.1136/adc.2007.122689.
- Background Wagner CL, Taylor SN, Dawodu A, Johnson DD, Hollis BW. Vitamin D and its role during pregnancy in attaining optimal health of mother and fetus. Nutrients. 2012 Mar;4(3):208-30. doi: 10.3390/nu4030208. Epub 2012 Mar 21.
- Background Dawodu A, Tsang RC. Maternal vitamin D status: effect on milk vitamin D content and vitamin D status of breastfeeding infants. Adv Nutr. 2012 May 1;3(3):353-61. doi: 10.3945/an.111.000950.
- Background Dawodu A, Wagner CL. Prevention of vitamin D deficiency in mothers and infants worldwide - a paradigm shift. Paediatr Int Child Health. 2012 Feb;32(1):3-13. doi: 10.1179/1465328111Y.0000000024.
- Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.
- Dawodu A, Saadi HF, Bekdache G, Javed Y, Altaye M, Hollis BW. Randomized controlled trial (RCT) of vitamin D supplementation in pregnancy in a population with endemic vitamin D deficiency. J Clin Endocrinol Metab. 2013 Jun;98(6):2337-46. doi: 10.1210/jc.2013-1154. Epub 2013 Apr 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 1600 iu | — |
| Subject | Cholecalciferol | Other / unclassified | 3600 iu | — |