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

Phase 3

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: Prenatal Vitamin; Drug: Cholecalciferol (Vitamin D3)

• Registration Number: NCT00610688
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 Timeline

• Study First Submitted: 2007-12-27
• Study Start: 2008-01
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-02-08
• Primary Completion: 2011-06
• Study Completion: 2012-04
• Results First Submitted: 2012-05-15
• Results First Submitted QC: 2013-06-05
• Results First Posted: 2013-06-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Prenatal Vitamin	Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
3	Prenatal Vitamin	Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).
Prenatal Vitamin D3	Prenatal Vitamin	Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D
2	Cholecalciferol (Vitamin D3)	Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
3	Cholecalciferol (Vitamin D3)	Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).

Primary Outcome Measures

Name	Time	Method
Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement	12, 16, 28 weeks and at maternal delivery and neonatal birth	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

Secondary Outcome Measures

Name	Time	Method
Birthweight of Newborn Infant	Measured at birth.	Growth of the Newborn Infant as Measured by Birthweight in grams.
Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth	At delivery	Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth

Trial Locations

Locations (2)

United Arab Emirated Unitersity; 🇦🇪 Al-Ain, Abu Dhabi, United Arab Emirates

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States