Evaluation of Vitamin D Requirements During Pregnancy

Phase 3

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: cholecalciferol (vitamin D3); Drug: cholecalciferol

• Registration Number: NCT00292591
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester. Mothers will be randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D status of women regardless of their ethnicity or race.

Detailed Description

The prevalence of hypovitaminosis D in reproductive aged African-American women occurs at a rate of \> 40%. Two factors have contributed to this public health problem: an inadequate DRI for vitamin D and avoidance of sun exposure/use of sunscreen. This startling rate of hypovitaminosis D requires that the DRI for vitamin D in pregnancy be evaluated in a detailed manner. The Cochrane Library (2002) released a report stating that there is insufficient data to evaluate the effects of vitamin D supplementation during pregnancy. Recently, the safety of prolonged supplementation with up to 25x's DRI (10,000 IU/day) was demonstrated in nonpregnant adults. It is essential to determine what dose of vitamin D is required to eliminate hypovitaminosis D during pregnancy and provide the fetus/neonate with adequate vitamin D stores during development and growth, particularly in darkly pigmented individuals. The aim of this research proposal, then, is to determine the efficacy, effectiveness, and safety of maternal vitamin D supplementation (as a function of ethnicity and UV exposure) in the prevention of hypovitaminosis D in the pregnant mother and her fetus/neonate. We hypothesize that darkly pigmented mothers will require substantially higher oral supplementation with vitamin D to eliminate hypovitaminosis D as compared to their Caucasian counterparts. We propose a comprehensive clinical trial to test our hypothesis. Mothers at 12 weeks' gestation will be randomized to one of three vitamin D treatment groups:

1. Control, 400-,

2. 2,000-, or

3. 4,000 IU/day to be continued throughout pregnancy.

Calcium and vitamin D homeostasis and skeletal remodeling in the mother will be monitored closely throughout the pregnancy. Bone density of the mother will be measured at 12 weeks' gestation and one-month postpartum. Follow-up growth and skeletal integrity assessments of the infant will be performed at birth, 1, 6 and 12 months stratified by infant feeding regime. Through these proposed studies, the prevalence of hypovitaminosis D among mothers, their developing fetuses and neonates, and the utility of maternal therapeutic intervention with vitamin D for both mother and fetus/infant will be assessed.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-16
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2016-06-28
• Results First Submitted QC: 2016-06-28
• Status Verified: 2016-08
• Results First Posted: 2016-08-09
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 501

Inclusion Criteria

1. Women who are within the ages of 16-45 years
2. In good general health
3. Less than 12 weeks pregnant (based on last menstrual period)

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Exclusion Criteria

1. Mothers with preexisting type I or type II diabetes
2. Mothers with preexisting hypertension
3. Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
4. Mothers with multiple fetuses (e.g., twins, triplets, etc.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cholecalciferol-400 IU	cholecalciferol (vitamin D3)	Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
cholecalciferol 4000 IU	cholecalciferol (vitamin D3)	Experimental group receiving 4000 IU/day cholecalciferol
cholecalciferol 2000 IU	cholecalciferol (vitamin D3)	Experimental group receiving 2000 IU total vitamin D3/day.
cholecalciferol-400 IU	cholecalciferol	Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
cholecalciferol 2000 IU	cholecalciferol	Experimental group receiving 2000 IU total vitamin D3/day.
cholecalciferol 4000 IU	cholecalciferol	Experimental group receiving 4000 IU/day cholecalciferol

Primary Outcome Measures

Name	Time	Method
25-Hydroxyvitamin D Concentration	7 months	Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States