HIV Infections, Human Immunodeficiency Virus (HIV), Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Human Immunodeficiency Virus (HIV), Complementary Therapies
Brief summary
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).
Detailed description
Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency
Interventions
DRUGVitamin D
Vitamin D 4000 IU will be administered to enrollees on the active comparator arm
OTHERPlacebo
Placebo pills will be administered to enrollees in this arm
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Endothelial Function | Baseline and 12 weeks | Endothelial function measured by flow mediated brachial artery dilation |
Secondary
| Measure | Time frame |
|---|---|
| Change in Serum 25-hydroxyvitamin D Concentration in Both Groups | Baseline and 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 15 participants were randomized to matching placebo for 12 weeks | 15 |
| Vitamin D 4000 IU 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks | 30 |
| Total | 45 |
Baseline characteristics
| Characteristic | Vitamin D 4000 IU | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 15 Participants | 45 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 8 | 40 years STANDARD_DEVIATION 10 | 45 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 30 participants | 15 participants | 45 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 25 Participants | 10 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 30 |
| serious Total, serious adverse events | 0 / 15 | 0 / 30 |
Outcome results
Primary
Change in Endothelial Function
Endothelial function measured by flow mediated brachial artery dilation
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Change in Endothelial Function | 0.29 percent change in endothelial function |
| Vitamin D 4000 IU | Change in Endothelial Function | 0.55 percent change in endothelial function |
Secondary
Change in Serum 25-hydroxyvitamin D Concentration in Both Groups
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Change in Serum 25-hydroxyvitamin D Concentration in Both Groups | -1.8 ng/mL |
| Vitamin D 4000 IU | Change in Serum 25-hydroxyvitamin D Concentration in Both Groups | 5.0 ng/mL |