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Vitamin D Supplement Study for Adolescents (VIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanbin Dong, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT00909454
First received: May 22, 2009
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Overweight
Obesity
Dietary Supplement: 2000 IU Vitamin D3 daily supplement
Dietary Supplement: 400 IU Vitamin D3 supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: V.I.P. Feasibility Study (Vitamin D Intake Project)

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Plasma 25-OH D level [ Time Frame: 3-4 months from baseline to post-testing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 3-4 months from baseline to post-testing ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2009
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily 2000 IU vitamin D supplement Dietary Supplement: 2000 IU Vitamin D3 daily supplement
2000 IU vitamin D3 supplement to be taken once daily over 4 months
Other Name: NatureMade Maximum Strength D Vitamin 2000 IU List NO. 2516
Active Comparator: Daily Vitamin D supplement 400 IU Dietary Supplement: 400 IU Vitamin D3 supplement
400 IU Vitamin D3 supplement to be taken daily over 4 months
Other Name: NatureMade D Vitamin 400 IU List No. 1688

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.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909454

Locations
United States, Georgia
Georgia Prevention Institute at Medical College of Georgia
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Yanbin Dong, MD, PhD Georgia Regents University
  More Information

No publications provided by Georgia Regents University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yanbin Dong, Professor, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT00909454     History of Changes
Other Study ID Numbers: 0901159
Study First Received: May 22, 2009
Last Updated: October 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Vitamin D deficiency
Adolescents
African Americans
Overweight
Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Vitamin D Deficiency
Avitaminosis
Body Weight
Deficiency Diseases
Malnutrition
Nutrition Disorders
Overnutrition
Signs and Symptoms
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014