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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-5h432f
Enrollment
Unknown
Registered
2020-09-17
Start date
2017-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1

Interventions

Experimental group
65 people with HIV with or without antiretroviral treatment received vitamin D supplementation (50,000 IU and 8,000 IU) Control group: 65 people with HIV with or without antiretroviral treatment recei
Dietary supplement

Sponsors

Universidade Federal do Piaui
Lead Sponsor
FUNDAÇÃO DE AMPARO A PESQUISA DO PIAUÍ- FAPEPI
Collaborator
Instituto De Doenças Tropicais Natan Portela
Collaborator

Eligibility

Age
20 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Brazil

Contacts

Public ContactAdriana;Adriana Paiva;Paiva

Universidade Federal do Piaui ;Universidade Federal do Piaui

aapaiva@ufpi.edu.com.br;aapaiva@ufpi.edu.com.br(86) 32155863;(86) 32155863

Outcome results

None listed

Source: REBEC (via WHO ICTRP)