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NCT01417351 · ClinicalTrials.gov registry record · NA
Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function
A NA study, sponsored by USDA, Western Human Nutrition Research Center.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01417351: Completed NA study, sponsored by USDA, Western Human Nutrition Research Center.
NCT01417351 is a NA study that has completed, run by USDA, Western Human Nutrition Research Center. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01417351, a NA study, has completed, sponsored by USDA, Western Human Nutrition Research Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis Medical Center are currently conducting a study on the effects of vitamin D supplementation during pregnancy on maternal health and immune function. The investigators believe that vitamin D supplementation at levels greater than the current recommendation is beneficial for maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due to an imbalance in immune function at the placenta. This randomized, double-blind study is designed to test this hypothesis. Pregnant women who participate in the study receive either 400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28 weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The investigators are also collecting data on clinical parameters, such as blood pressure and glucose tolerance.
Primary Outcome
Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry.
Interventions
- DIETARY_SUPPLEMENT 400 IU vitamin D3
- DIETARY_SUPPLEMENT 2,000 IU Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-05 |
| Phase | NA |
What the finished NCT01417351 record still lists
NCT01417351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which 400 IU vitamin D3 is the first listed.
NCT01417351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01417351 about?
NCT01417351 is a clinical study titled "Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function". Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis Medical Center are currently conducting a study on the effects of vitamin D supplementation during pregnancy on maternal health and immune function. The investigators believe that vitamin D supplementation at ...
What is the current status of trial NCT01417351?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2010-08. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01417351?
The interventions under investigation include: 400 IU vitamin D3 (DIETARY_SUPPLEMENT), 2,000 IU Vitamin D3 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01417351?
This trial is sponsored by USDA, Western Human Nutrition Research Center, which has 47 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01417351's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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