Changes in vitamin D metabolism in HIV-infected patients.

Not Applicable

• Conditions: Vitamin D Deficiency

• Registration Number: RBR-92mmc7
• Lead Sponsor: Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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 Outcome Measures

Name	Time	Method
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.<br>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)