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Completed

NCT Number: NCT00909454

Vitamin D Supplement Study for Adolescents

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Body Weight Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Prevention Institute at Medical College of Georgia

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2000 IU Vitamin D3 daily supplement

Dietary Supplement

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

Other names: NatureMade Maximum Strength D Vitamin 2000 IU List NO. 2516

400 IU Vitamin D3 supplement

Dietary Supplement

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

Other names: NatureMade D Vitamin 400 IU List No. 1688

Primary outcomes

  1. Plasma 25-OH D level

    Time frame: 3-4 months from baseline to post-testing

Secondary outcomes

  1. Blood pressure

    Time frame: 3-4 months from baseline to post-testing

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

V.I.P. Feasibility Study (Vitamin D Intake Project)

Acronym: VIP

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 28, 2009
Registry last updated
Oct 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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