Bone Health and Vitamin D Status

Completed

• Conditions: Vitamin D Deficiency; HIV Infection; Osteopenia

• Registration Number: NCT01634607
• Lead Sponsor: Thai Red Cross AIDS Research Centre

Brief Summary

This study will compare and assess the prevalence of osteopenia and vitamin D deficiency as well as effects of TDF on the patients' bone among HIV positive and negative patients.

Detailed Description

To determine the prevalence of osteopenia and vitamin D deficiency in HIV-1 infected, HAART naive Thai patients compared to HIV-1 uninfected Thai participants. Furthermore, to determine the change in BMD after twelve months in HIV-1 infected Thai patients on a TDF-based HAART regimen compared to patients on a non-TDF containing regimen.

Study Timeline

• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Study Start: 2019-12-01
• Primary Completion: 2021-07-15
• Status Verified: 2021-10
• Last Update Submitted: 2023-02-15
• Study Completion: 2023-02-16
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

• HIV uninfected:

  • HIV negative confirmed by HIV testing
  • Age 30 years and older
  • Thai nationality
  • Signed informed consent form for the study

• HIV-infected, HAART naïve:

  • Recorded HIV infection
  • Age 30 years and older
  • Thai nationality
  • Signed informed consent form for the study

• HIV-infected, HAART group:

  • Recorded HIV infection
  • Age 30 years and older
  • Thai nationality
  • HAART naïve at baseline, planned to start HAART within 90 days. Past exposure to antiretroviral therapy during pregnancy for the prevention of mother to child transmission of HIV ≥ 3 months prior to screening will be allowed
  • Signed informed consent form for the study

Exclusion Criteria

• HIV uninfected

  • Currently pregnant or lactating
  • Recent hospitalization
  • Use of anticonvulsants, steroids or vitamin D supplements

• HIV-infected, HAART naïve

  • CD4 < 350
  • Currently pregnant/lactating
  • Recent hospitalization
  • Signs of wasting
  • Use of anticonvulsants, steroids or vitamin D supplements

• HIV-infected, HAART group:

  • Prior antiretroviral therapy use
  • Currently pregnant/lactating
  • Recent hospitalization
  • Signs of wasting
  • Active opportunistic infection
  • Use of anticonvulsants, steroids or vitamin D supplements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vitamin D deficiency	60 months	development of vitamin D deficiency
osteopenia	60 months	development of osteopenia
BMD	1 year	changes of BMD

Trial Locations

Locations (1)

The Thai Red Cross AIDS Research Centre; 🇹🇭 Pathum Wan, Bangkok, Thailand