HIV, Vitamin D Deficiency
Conditions
Keywords
HIV, Vitamin D, HAART
Brief summary
This is a research study to look at vitamin D deficiency (low levels) in men and women with HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If your levels are low, and you choose to start using vitamin D supplements, the investigators would like to take some blood before and after you start using vitamin D to see how this affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study. If you and your physician decide that you should continue taking vitamin D supplements after that time, you will be responsible for purchasing your own vitamin D supplements.
Interventions
DIETARY_SUPPLEMENTVitamin D
50,000 IU vitamin D3 twice weekly for 5 weeks, followed by 2000 IU daily maintenance supplementation to complete 12 weeks. At the end of the 12-week period, 25(OH)D levels will be checked. If the subject is still deficient, he/she may undergo a second period of supplementation (at the discretion of their provider) to complete a total of 24 weeks. After 24 weeks, we anticipate all subjects will be kept on daily maintenance supplementation by their primary physicians.
Sponsors
University of California, Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* HIV-positive men and women age 18 and older. * HIV-1 RNA documented to be \< 200 copies/mL on their current ART regimen, with supporting viral load documentation in the 24 weeks prior to study entry. * Subjects must receive primary HIV care at the UCLA CARE center. * Subjects must be undergoing screening for vitamin D deficiency by their primary care provider at the time of study entry, or have undergone vitamin D screening in the 90 days prior to consent without yet initiating vitamin D supplementation (for insufficient subjects). * Ability and willingness of subject to provide informed consent
Exclusion criteria
* Use of vitamin D supplementation (not including 400 IU daily, the amount in a standard multivitamin) at the time of screening. * HIV-infected subjects not on ART. * HIV-infected subjects not suppressed on their current ART regimen (HIV-1 RNA \> 200 copies/mL in the 6 months prior to screening).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation. | 12 weeks | Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Sufficient HIV-infected men and women on stable ART with HIV-1 RNA \<200 copies/mL and reported taking daily vitamin D \<400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation. | 40 |
| Vitamin D Insufficient HIV-infected men and women on stable ART with HIV-1 RNA \<200 copies/mL and reported taking daily vitamin D \<400 IU were eligible to participate. Subjects with 25(OH)D \<30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. | 82 |
| Total | 122 |
Baseline characteristics
| Characteristic | Vitamin D Sufficient | Vitamin D Insufficient | Total |
|---|---|---|---|
| Age, Continuous | 49 years | 48 years | 48 years |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 38 Participants | 78 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 |
Outcome results
Primary
Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.
Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.
Time frame: 12 weeks
Population: After 12 weeks of oral vitamin D supplementation, serum 25(OH)D levels were measured in the Vitamin D Insufficient arm. 81% (n=66) of insufficient persons achieved 25(OH)D ≥30ng/mL (p=0.32 vs. historical controls).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamin D Insufficient | Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation. | 81 percentage of participants |
Comparison: We predicted that HIV-infected subjects would have a 70% twelve-week repletion success rate compared to 85% among historical controls.Eighty subjects provided 91% power to detect a 12-week repletion rate statistically different than 85% (95% confidence interval (CI) 60%, 80%).p-value: <0.0595% CI: [60, 80]Exact binomial