Vitamin D Supplement Study for Adolescents

NCT ID: NCT00909454

Last Updated: 2011-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Vitamin D Deficiency Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Daily 2000 IU vitamin D supplement

Group Type EXPERIMENTAL

2000 IU Vitamin D3 daily supplement

Intervention Type DIETARY_SUPPLEMENT

2000 IU vitamin D3 supplement to be taken once daily over 4 months

Daily Vitamin D supplement 400 IU

Group Type ACTIVE_COMPARATOR

400 IU Vitamin D3 supplement

Intervention Type DIETARY_SUPPLEMENT

400 IU Vitamin D3 supplement to be taken daily over 4 months

Interventions

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2000 IU Vitamin D3 daily supplement

2000 IU vitamin D3 supplement to be taken once daily over 4 months

Intervention Type DIETARY_SUPPLEMENT

400 IU Vitamin D3 supplement

400 IU Vitamin D3 supplement to be taken daily over 4 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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NatureMade Maximum Strength D Vitamin 2000 IU List NO. 2516 NatureMade D Vitamin 400 IU List No. 1688

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Yanbin Dong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanbin Dong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

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Georgia Prevention Institute at Medical College of Georgia

Augusta, Georgia, United States

Site Status

Countries

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United States

References

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Dong Y, Stallmann-Jorgensen IS, Pollock NK, Harris RA, Keeton D, Huang Y, Li K, Bassali R, Guo DH, Thomas J, Pierce GL, White J, Holick MF, Zhu H. A 16-week randomized clinical trial of 2000 international units daily vitamin D3 supplementation in black youth: 25-hydroxyvitamin D, adiposity, and arterial stiffness. J Clin Endocrinol Metab. 2010 Oct;95(10):4584-91. doi: 10.1210/jc.2010-0606. Epub 2010 Jul 21.

Reference Type DERIVED
PMID: 20660028 (View on PubMed)

Other Identifiers

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0901159

Identifier Type: -

Identifier Source: org_study_id