Vitamin D Supplement Study for Adolescents (VIP)

Augusta University

Status: Completed

Conditions: Overweight; Vitamin D Deficiency; Obesity

Treatments: Dietary Supplement: 2000 IU Vitamin D3 daily supplement; Dietary Supplement: 400 IU Vitamin D3 supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT00909454

0901159

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 14 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

45 participants in 2 patient groups

Daily 2000 IU vitamin D supplement

Experimental group

Treatment:

Dietary Supplement: 2000 IU Vitamin D3 daily supplement

Daily Vitamin D supplement 400 IU

Active Comparator group

Treatment:

Dietary Supplement: 400 IU Vitamin D3 supplement