Effectiveness of Vitamin D Supplementation

NCT02513823 | Terminated Results

• 1 other identifier: 11089
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

blood pressure; vitamin D

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Vitamin D Supplementation on Reducing Blood Pressure

  Changes in systolic and diastolic blood pressure will be measured at baseline and following vitamin D supplementation for 10 weeks in African American healthy pre-menopausal women

  Baseline and 10 weeks

Secondary Outcomes (1)

• Effectiveness of Vitamin d Supplementation on Improving Endothelial Function

  Baseline and 10 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

2,000 IU of vitamin D given to African American women for 10 weeks

Dietary Supplement: 2,000 International Units (IU)of vitamin D3

Interventions

2,000 International Units (IU)of vitamin D3 DIETARY_SUPPLEMENT

2,000 IU vitamin D taken daily for 10 weeks

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Texas Woman's University: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Carolyn Moore
• Organization: Texas Woman's University

cmoore8@twu.edu

713-794-2377

Study Officials

• Carolyn Moore, PHD, RD, LD

  Methodist Hosptial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 3, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: October 14, 2016
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)