Phase 3
Completed N=501
Evaluation of Vitamin D Requirements During Pregnancy
Source: ClinicalTrials.gov NCT00292591 ↗Enrolled (actual)
501
Serious AEs
5.2%
Results posted
Aug 2016
Primary outcomePrimary: 25-Hydroxyvitamin D Concentration — 32.5; 41.0; 45.7 ng/mL
◆ Published Evidence
Highly cited
843citations · ~56 / year
Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness.
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.
Linked Publications (4)
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Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness.
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Vitamin D requirements and supplementation during pregnancy.
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Vitamin D supplementation for women during pregnancy.
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Bone mineral density during pregnancy in women participating in a randomized controlled trial of vitamin D supplementation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 25-Hydroxyvitamin D Concentration |
32.5; 41.0; 45.7 | — |
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT00292591) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.