Vitamin D Deficiency
Conditions
Interventions
Experimental group: 140 individuals with vitamin D deficiency will receive vitamin D supplementation orally 50,000 IU of vitamin D3 twice a week for five weeks followed by maintenance 2,000 IU daily s
Dietary supplement
Sponsors
Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas
Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas
Eligibility
Inclusion criteria
Inclusion criteria: HIV-infected men and women aged 18 years or more; having HIV-1 RNA < 50 copies / mL proven with their current antiretroviral regimen (within the 24 weeks prior to study entry); participants should receive HIV primary care in the Evandro Chagas Research Institute (IPEC) at the time to study entry; participants should have capacity and willingness to sign the written informed consent prior to the initiation of the study procedures.
Exclusion criteria
Exclusion criteria: Persons receiving vitamin D supplementation > (not including standard multivitamin once a day); HIV-infected persons not in use antiretroviral therapy; HIV-infected persons without viral suppression with their current antiretroviral regimen (HIV-1 RNA> 50 copies/mL within the 6 months prior to screening).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Range serum levels of Vitamin D greater than 30 ng / ml at week 24 of the study to the participants submitted to serum supplementation checked by chemiluminescence analysis. Outcome obtained: 83% (n=52/63, 95% CI 71%-90%) of participants reached serum levels of Vitamin D greater than 30 ng / ml at week 24 of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Modification of fasting blood glucose levels, insulin, insulin resistance, fasting lipids (total cholesterol, HDL, LDL and triglycerides), adiponectin, leptin, fructosamine and HbA1c in HIV-infected participants with viral suppression and vitamin levels D below 30 ng / ml checked by serum biochemical analysis before the supplementation and after supplementation with vitamin D. Outcome obtained: Was observed that compared to baseline, week 24 CD4+ T lymphocyte counts increased. (baseline visit = 689 cells/mm³ week 24 visit = 712 cells/mm³) | — |
Countries
Brazil
Contacts
Public ContactBeatriz Grinsztejn
Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas
Outcome results
None listed