Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function

USDA, Western Human Nutrition Research Center

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: 2,000 IU Vitamin D3; Dietary Supplement: 400 IU vitamin D3

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01417351

217516

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

400 IU Vitamin D3

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: 400 IU vitamin D3

2,000 IU Vitamin D3

Experimental group

Description:

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.

Treatment:

Dietary Supplement: 2,000 IU Vitamin D3