N/A
N=62
Vitamin D Supplements for HIV-positive Patients on cART
HIV-associated Co-morbidities
Bottom Line
View on ClinicalTrials.gov: NCT01295034 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: 25(OH)D Levels — 13; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- conventional vitamin D treatment (Dietary_supplement); tiered/titrated vitamin D dosing (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Andrea Branch
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 25(OH)D Levels |
13; 20 | — |
| SECONDARY CD4+T Cell Count |
26; 40 | — |
Summary
The ability of vitamin D to modulate the immune system and strengthen bones may mitigate the adverse medication consequences of HIV/AIDS, but little is known about either the health benefits of vitamin D supplements, or about the optimal dosing regimen for patients on highly active antiretroviral therapy (HAART). This trial is a comparison of two regimens for administering vitamin D and calcium to HIV-positive individuals taking antiviral medications. This study will help physicians make evidence-based decisions about the most effective way to use vitamin D in their patients and enable the design of large multi-center trials in the future.
Eligibility Criteria
Inclusion Criteria
- age, 18-70 yr
- HIV-infected
- on a stable HAART regimen for at least 12 mo with an undetectable HIV viral load for 6-mo
- willing to participate
- not receiving vitamin D supplementation in a form other than vitamin D2 or vitamin D3
- not receiving treatment for bone disease
- not receiving medications known to alter bone mineralization
- not suffering from conditions known to affect vitamin D, calcium, and/or phosphate levels (including clinically significant hypocalcemia, primary hyperparathyroidism)
- not experiencing kidney disease based on GFR > 60 min/ml/1.73 m2, 10) 25(OH)D level < 25 ng/ml
- not meeting criteria of the National Osteoporosis Foundation for established bone disease (osteoporosis, osteomalacia) requiring immediate treatment
- not consuming more than 2.0 gm of calcium/day in food and supplements combined outside the trial
- not consuming more than 800IU/day of vitamin D outside the trial
- not suffering from an unstable medical condition likely to preclude participation in a 12 month trial
- able to ingest and absorb food and nutrients
- not pregnant or planning to become pregnant.
Exclusion Criteria
- No history or evidence of HIV infection
- HIV viral load positive
- outside the age range
Data sourced from ClinicalTrials.gov (NCT01295034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.