V.I.P. Feasibility Study (Vitamin D Intake Project)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Augusta University
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Plasma 25-OH D level
Study Overview
Brief Summary
The purpose of this study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.
Detailed Description
To determine the feasibility of African American teenagers taking a daily vitamin D supplement over a 4 month period in terms of compliance and practical implementation.
To determine the differences in response in blood 25-OH D level between those randomly assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are differences in blood 25-OH D level response depending on subject gender and overweight/obese versus healthy-weight status.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 14 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy African American Adolescents
Exclusion Criteria
- •Hypertension
- •Pregnancy
- •Medications that affect study outcome measures
- •Use of other vitamin and/or mineral supplement or herbal supplements
- •Individuals of other races
Outcomes
Primary Outcomes
Plasma 25-OH D level
Time Frame: 3-4 months from baseline to post-testing
Secondary Outcomes
- Blood pressure(3-4 months from baseline to post-testing)
Investigators
Yanbin Dong
Professor
Augusta University