| December 27, 2007
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| February 8, 2008
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| May 15, 2012
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| June 7, 2013
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| June 7, 2013
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| January 2008
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| June 2011 (Final data collection date for primary outcome measure)
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| Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement [ Time Frame: 29 weeks ] Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement
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| Maternal and neonatal serum 25-hydroxyvitamin D measurement [ Time Frame: 29 weeks ]
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| Complete list of historical versions of study NCT00610688 on ClinicalTrials.gov Archive Site
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| Growth of the newborn infant as measured by weight, crown-heel length and head circumference at birth [ Time Frame: At delivery ]
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| Not Provided
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| Not Provided
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| Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants |
| High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants |
| 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. |
| Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth. |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention |
| Vitamin D Deficiency |
- Drug: Prenatal Vitamin
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
- Drug: Cholecalciferol (Vitamin D3)
Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
- Drug: Cholecalciferol (Vitamin D3)
Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
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- Placebo Comparator: Prenatal Vitamin D3
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D
Intervention: Drug: Prenatal Vitamin
- Experimental: 2
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
Interventions:
- Drug: Prenatal Vitamin
- Drug: Cholecalciferol (Vitamin D3)
- Experimental: 3
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).
Interventions:
- Drug: Prenatal Vitamin
- Drug: Cholecalciferol (Vitamin D3)
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- 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.
- 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.
- 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.
- Dawodu A, Wagner CL. Mother-child vitamin D deficiency: an international perspective. Arch Dis Child. 2007 Sep;92(9):737-40.
- 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. Review.
- 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. Review.
- 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. Review.
- 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.
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| Completed |
| 192 |
| April 2012 |
| June 2011 (Final data collection date for primary outcome measure) |
Inclusion Criteria:
- Women who are within the ages of 18-45 years
- In good general health
- 12 weeks pregnant (based on last menstrual period)
Exclusion Criteria:
- Mothers with preexisting type I or type II diabetes
- Mothers with preexisting hypertension
- Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
- Mothers with multiple fetuses (e.g., twins, triplets, etc.)
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| Sexes Eligible for Study: |
Female |
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| 18 Years to 45 Years (Adult) |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United Arab Emirates, United States |
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| |
| NCT00610688 |
| PA 03-103 |
| Yes |
| Not Provided |
| Not Provided |
| Children's Hospital Medical Center, Cincinnati |
| Children's Hospital Medical Center, Cincinnati |
- United Arab Emirates University
- Thrasher Research Fund
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| Principal Investigator: |
Adekunle Dawodu, MBBS |
Children's Hospital Medical Center, Cincinnati |
| Principal Investigator: |
Hussein F Saadi, MD |
United Arab Emirates University |
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| Children's Hospital Medical Center, Cincinnati |
| June 2013 |
