Title
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
Phase
Phase 3Lead Sponsor
University of CincinnatiStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Vitamin D DeficiencyIntervention/Treatment
vitamin d3 multivitamins ...Study Participants
192The 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.
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).
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.)
| Event Type | Organ System | Event Term |
|---|
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
Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth
Growth of the Newborn Infant as Measured by Birthweight in grams.
