Bone Health and Vitamin D Status

Bone Health and Vitamin D Status in Thai HIV-1 Infected and Uninfected Adults (A Substudy of TNT-HIV 003: Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01634607

Acronym

BHVD

Enrollment

235

Registered

2012-07-06

Start date

2019-12-01

Completion date

2023-02-16

Last updated

2023-02-17

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

Conditions

HIV Infection, Osteopenia, Vitamin D Deficiency

Keywords

osteopenia, vitamin D deficiency, HIV-infected patients, bone health, Bone mineral density (BMD), HIV-uninfected patients, effects of TDF on the patients' bone

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
osteopenia	60 months	development of osteopenia
vitamin D deficiency	60 months	development of vitamin D deficiency
BMD	1 year	changes of BMD

Countries

Thailand

Outcome results