Phase 3
Completed N=190
Vitamin D Supplementation in HIV Youth
Source: ClinicalTrials.gov NCT01523496 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Changes in Serum 25(OH)D3 Levels — 11; 22; 7.5; 25 ng/mL
◆ Published Evidence
Established
60citations · ~8 / year
Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth.
Summary
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
Linked Publications (3)
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Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth.
-
Vitamin D and bone loss in HIV.
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Neurocognitive dysfunction in HIV-infected youth: investigating the relationship with immune activation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Serum 25(OH)D3 Levels |
11; 22; 7.5; 25 | — |
| SECONDARY Changes in Vitamin D Binding Protein (VDBP) |
3.9; -8.9; -11.3; -11.7 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 8-25
- Documented HIV-1 infection
- On stable antiretroviral therapy for > 3 months
- Cumulative antiretroviral therapy of at least 6 months
- 25(OH)D level 400 IU daily regular vitamin D intake
- Parathyroid/calcium disorders
- Active malignancy
- Pregnancy/intent to become pregnant/breastfeeding
- Chronic infectious/inflammatory conditions
- Creatinine clearance 2.5 upper limit of normal
- Diabetes requiring hypoglycemic agents
- Known coronary artery disease
- Inability to swallow pills
Data sourced from ClinicalTrials.gov (NCT01523496) and the linked publication. 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. Informational only — not medical advice.