Clinical trial NCT01417351: Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function
Official title: Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: pregnancy
immune function
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: University of California, Davis
First posted: 2011-08-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Less than 20 weeks gestation
* Over 18 years of age
* Able to swallow nutritional supplements

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in T-cell cytokine expression
timeFrame: 16-20 wks, 26-28 wks, and 36 wks gestation
Secondary outcomes:
measure: Change in Vitamin D status
timeFrame: 16-20 wks, 26-28 wks, 36 wks gestation
measure: Change in innate immune function
timeFrame: 16-20 wks, 26-28 wks, 36 wks gestation
measure: Change in blood pressure
timeFrame: 16-20 wks, 26-28 wks, 36 wks gestation
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA-Western Human Nutrition Research Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center Obstetrics & Gynecology
state: California
Study officials:
affiliation: USDA, ARS, Western Human Nutrition Research Center
name: Charles B Stephensen, PhD
role: STUDY_DIRECTOR
References:
citation: Zerofsky 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.