Effectiveness of Vitamin D Supplementation

Stopped early · Not applicable

Conditions studied: Elevated Blood Pressure, Endothelial Dysfunction

In brief

This pilot study will examine the effectiveness of vitamin D supplementation on reducing blood pressure and improving endothelial function. Premenopausal African American women will be recruited. Participants will be instructed to record food intake for three days to estimate usual dietary intake at baseline and at the 10th week. At the baseline clinic visit a 10 week supply of vitamin D3 supplements (2,000 IU/day; Nature Made ®) will be given to participants and log sheets provided to record supplement intake. To answer the primary research questions, within subjects repeated measures analysis of variance (ANOVA) tests will be conducted to test if any differences in blood pressure, serum 25(OH)D concentrations, and RHI are statistically different after 10 weeks of supplementation with 2,000 IU/d of vitamin D. Exploratory multivariate linear regression models will be constructed to determine relationships between vitamin D status and vascular function parameters (blood pressure, RHI) before and after adjustment for age and BMI.

Key facts

Study ID

NCT02513823

Run by

Texas Woman's University

People needed

27

Starts

2015-12-01

Expected to finish

2016-10-14

Last updated by the study team

2019-10-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy pre-menomausal African American women

You may not qualify if…

• History of elevated blood pressure >140/90 mm Hg
• Pregnant or planning to become pregnant in the next three months
• Lactating
• Known Crohn's
• Inflammatory bowel disease
• Previous bowel resections
• Bariatric surgeries, or psoriasis
• Artificial or long fingernails they do not want to cut for testing
• Regularly taking medications that might affect endothelial function such as anti-inflammatory medications, statins, anti-hypertensive medication, daily aspirin, non-SSRI psychotropic medication, and dietary supplements including vitamin D supplements

Where it is running

• Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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