Effect of vitamin D3 supplementation on viral load and recovery of TCD4 + cells in HIV patients on antiretroviral therapy assisted by SUS

Phase 2

• Conditions: HIV-1; Acquired Immunodeficiency Syndrome; Nutritional status; B04.820.650.589.650.350.400; C02.782.815.616.400.040; G07.203.650.650

• Registration Number: RBR-5h432f
• Lead Sponsor: niversidade Federal do Piaui

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

being under treatment in Teresina; being aged 20 years; never having used ART; who are not using vitamin or mineral supplementation; who do not have a diagnosis of metabolic diseases, diabetes, metabolic syndrome, thyroid disorders, bone diseases being treated, chronic renal failure, liver disease, gastric diseases or disabsorptive syndromes, neoplasms; pregnant and lactating women.

Exclusion Criteria

not complying with the proposed antiretroviral regimen or the placebo, supplement intake regimen during the six-month follow-up; pregnancy during follow-up; diagnosis of metabolic diseases, bone diseases being treated, chronic renal failure, liver disease, gastric diseases or disabsorptive syndromes, neoplasms during follow-up.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presentation of the expected outcome (Analyze the effect of vitamin D3 supplementation on viral load and levels of CD4 cells in HIV-infected individuals using antiretroviral therapy (ART), assisted by the Unified Health System (SUS) in Teresina-PI and expected levels of TCD4+ cells to increase)

Secondary Outcome Measures

Name	Time	Method
Presentation of the expected outcome (Analyze the effect of vitamin D supplementation on viral load and TCD4 cell levels in HIV-infected individuals using antiretroviral therapy (ART), assisted by the Unified Health System (SUS) in Teresina-PI and expected not to find that the levels of TCD4+ cells increase)