Bone Health and Vitamin D Status

Vitamin D Deficiency Clinical Trial

— BHVD  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634607
• Other study ID #: TNT-HIV 003.1
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: February 16, 2023

Study information

• Verified date: October 2021
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: February 16, 2023
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• HIV Infection
• Osteopenia
• Vitamin D Deficiency

Locations

Country	Name	City	State
Thailand	The Thai Red Cross AIDS Research Centre	Pathum Wan	Bangkok

Sponsors (5)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Bamrasnaradura Infectious Diseases Institute, HIV Netherlands Australia Thailand Research Collaboration, ViiV Healthcare

Country where clinical trial is conducted

Thailand, 

Outcome

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