Study of Vitamin D and Effect on Heart Disease and Insulin Resistance

University Hospitals (UH)

Status and phase: Completed; Phase 2

Conditions: Vitamin D Deficiency; Human Immunodeficiency Virus (HIV); HIV Infections

Treatments: Other: Placebo; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01093417

11-09-30

Details and patient eligibility

About

The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).

Full description

Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV infected
• HIV-RNA < 400 copies/ml at study entry and for 12 wks. prior
• 25-hydroxyvitamin D level <20
• On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry

Exclusion criteria

• Pregnancy or Breast Feeding
• Diabetes
• Creatinine Clearance <50
• Any active infectious or inflammatory condition
• aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 within 6 months prior to study entry

Trial design

45 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants that have been randomized into this arm will receive placebo pills.

Treatment:

Other: Placebo

Vitamin D 4000 IU

Active Comparator group

Description:

Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily.

Treatment:

Drug: Vitamin D