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Clinical Trials/NCT00292591
NCT00292591CompletedPhase 3

Evaluation of Vitamin D Requirements During Pregnancy

Medical University of South Carolina1 site in 1 country501 target enrollmentStarted: January 2004Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
501
Locations
1
Primary Endpoint
25-Hydroxyvitamin D Concentration

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to 45 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Women who are within the ages of 16-45 years
  • In good general health
  • Less than 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.)

Arms & Interventions

cholecalciferol-400 IU

Active Comparator

Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day

Intervention: cholecalciferol (vitamin D3) (Drug)

cholecalciferol-400 IU

Active Comparator

Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day

Intervention: cholecalciferol (Drug)

cholecalciferol 2000 IU

Experimental

Experimental group receiving 2000 IU total vitamin D3/day.

Intervention: cholecalciferol (vitamin D3) (Drug)

cholecalciferol 2000 IU

Experimental

Experimental group receiving 2000 IU total vitamin D3/day.

Intervention: cholecalciferol (Drug)

cholecalciferol 4000 IU

Experimental

Experimental group receiving 4000 IU/day cholecalciferol

Intervention: cholecalciferol (vitamin D3) (Drug)

cholecalciferol 4000 IU

Experimental

Experimental group receiving 4000 IU/day cholecalciferol

Intervention: cholecalciferol (Drug)

Outcomes

Primary Outcomes

25-Hydroxyvitamin D Concentration

Time Frame: 7 months

Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carol Wagner

Professor of Pediatrics

Medical University of South Carolina

Study Sites (1)

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