Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function
Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial
1 other identifier
interventional
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2010
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 12, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJuly 23, 2013
July 1, 2013
2.8 years
August 12, 2011
July 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in T-cell cytokine expression
Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry.
16-20 wks, 26-28 wks, and 36 wks gestation
Secondary Outcomes (3)
Change in Vitamin D status
16-20 wks, 26-28 wks, 36 wks gestation
Change in innate immune function
16-20 wks, 26-28 wks, 36 wks gestation
Change in blood pressure
16-20 wks, 26-28 wks, 36 wks gestation
Study Arms (2)
400 IU Vitamin D3
PLACEBO COMPARATORWomen in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement.
2,000 IU Vitamin D3
EXPERIMENTALWomen in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement.
Interventions
Women in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement.
Women in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement.
Eligibility Criteria
You may qualify if:
- Pregnant women
- Less than 20 weeks gestation
- Over 18 years of age
- Able to swallow nutritional supplements
You may not qualify if:
- Use of medications known to affect vitamin D metabolism
- Diagnosis of type 1 diabetes
- History of thyroid, renal, or liver disease
- Problems with digestion or absorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
USDA-Western Human Nutrition Research Center
Davis, California, 95616, United States
UC Davis Medical Center Obstetrics & Gynecology
Sacramento, California, 95817, United States
Related Publications (2)
Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.
PMID: 39077939DERIVEDZerofsky MS, Jacoby BN, Pedersen TL, Stephensen CB. Daily Cholecalciferol Supplementation during Pregnancy Alters Markers of Regulatory Immunity, Inflammation, and Clinical Outcomes in a Randomized Controlled Trial. J Nutr. 2016 Nov;146(11):2388-2397. doi: 10.3945/jn.116.231480. Epub 2016 Sep 21.
PMID: 27655755DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Charles B Stephensen, PhD
USDA, ARS, Western Human Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2011
First Posted
August 16, 2011
Study Start
August 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
July 23, 2013
Record last verified: 2013-07