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Effectiveness of Vitamin D Supplementation

NCT02513823 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-10-04

Study results available
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Summary

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.

Conditions

  • Elevated Blood Pressure
  • Endothelial Dysfunction

Interventions

DIETARY_SUPPLEMENT

2,000 International Units (IU)of vitamin D3

2,000 IU vitamin D taken daily for 10 weeks

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Texas Woman's University

    lead OTHER

Principal Investigators

  • Carolyn Moore, PHD, RD, LD · Methodist Hosptial

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2016-08-01
Completion
2016-10-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513823 on ClinicalTrials.gov