NCT00909454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2009

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 17, 2011

Status Verified

October 1, 2011

Enrollment Period

28 days

First QC Date

May 22, 2009

Last Update Submit

October 14, 2011

Conditions

Vitamin D DeficiencyOverweightObesity

Keywords

Vitamin D deficiencyAdolescentsAfrican AmericansOverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Plasma 25-OH D level

    3-4 months from baseline to post-testing

Secondary Outcomes (1)

  • Blood pressure

    3-4 months from baseline to post-testing

Study Arms (2)

Daily 2000 IU vitamin D supplement

EXPERIMENTAL
Dietary Supplement: 2000 IU Vitamin D3 daily supplement

Daily Vitamin D supplement 400 IU

ACTIVE COMPARATOR
Dietary Supplement: 400 IU Vitamin D3 supplement

Interventions

2000 IU Vitamin D3 daily supplementDIETARY_SUPPLEMENT

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

Also known as: NatureMade Maximum Strength D Vitamin 2000 IU List NO. 2516
Daily 2000 IU vitamin D supplement
400 IU Vitamin D3 supplementDIETARY_SUPPLEMENT

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

Also known as: NatureMade D Vitamin 400 IU List No. 1688
Daily Vitamin D supplement 400 IU

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy African American Adolescents

You may not qualify if:

  • Hypertension
  • Pregnancy
  • Medications that affect study outcome measures
  • Use of other vitamin and/or mineral supplement or herbal supplements
  • Individuals of other races

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Prevention Institute at Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

  • 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.

    PMID: 20660028DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyOverweightObesity

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yanbin Dong, MD, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 28, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

October 17, 2011

Record last verified: 2011-10

Locations

US(1)