Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

Tracking Information
First Submitted Date ICMJE	December 27, 2007
First Posted Date ICMJE	February 8, 2008
Results First Submitted Date	May 15, 2012
Results First Posted Date	June 7, 2013
Last Update Posted Date	June 7, 2013
Study Start Date ICMJE	January 2008
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 5, 2013)	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
Original Primary Outcome Measures ICMJE; (submitted: January 28, 2008)	Maternal and neonatal serum 25-hydroxyvitamin D measurement [ Time Frame: 29 weeks ]
Change History	Complete list of historical versions of study NCT00610688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 5, 2013)	Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth [ Time Frame: At delivery ]Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth; Birthweight of Newborn Infant [ Time Frame: Measured at birth. ]Growth of the Newborn Infant as Measured by Birthweight in grams.
Original Secondary Outcome Measures ICMJE; (submitted: January 28, 2008)	Growth of the newborn infant as measured by weight, crown-heel length and head circumference at birth [ Time Frame: At delivery ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Official Title ICMJE	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
Brief 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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Prevention
Condition ICMJE	Vitamin D Deficiency
Intervention ICMJE	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
Study Arms	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)
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 5, 2013)	192
Original Estimated Enrollment ICMJE; (submitted: January 28, 2008)	180
Actual Study Completion Date	April 2012
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.)
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 45 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United Arab Emirates, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00610688
Other Study ID Numbers ICMJE	PA 03-103
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Children's Hospital Medical Center, Cincinnati
Study Sponsor ICMJE	Children's Hospital Medical Center, Cincinnati
Collaborators ICMJE	United Arab Emirates University; Thrasher Research Fund
Investigators ICMJE	Principal Investigator: Adekunle Dawodu, MBBS Children's Hospital Medical Center, Cincinnati Principal Investigator: Hussein F Saadi, MD United Arab Emirates University
PRS Account	Children's Hospital Medical Center, Cincinnati
Verification Date	June 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP