Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this study is to determine whether calcium and vitamin D supplement can attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil fumarate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 11, 2016
June 1, 2016
9 months
July 6, 2016
July 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
percentage change of bone density
24 weeks
Secondary Outcomes (1)
change in 25(OH)D level
24 weeks
Study Arms (2)
TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement
ACTIVE COMPARATOROnce daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study
TDF/3TC or FTC/EFV
OTHERthe subjects in this arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient.
Interventions
Once daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study
arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient.
Eligibility Criteria
You may qualify if:
- HIV-1-infected patients who start 3TC or FTC,TDF and EFV within 3 months before enrollment
- Age 18-50 years
You may not qualify if:
- CrCl \<60mL/min/1.73 m2 ¶-
- CaCO3 supplement \>500 mg/day or vitamin D supplement \>800 IU/day
- Steroid used (equivalent to prednisolone\> 5 mg/day more than 3 months )
- Osteoporosis treatment
- Serum Ca \>10.5 g/dL
- History fragility fracture
- Pregnancy or breastfeeding
- Secondary amenorrhea
- Hyperthyroidism
- History of kidney stone
- Current active opportunistic infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Patawee Boontanondha
Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2016
First Posted
July 11, 2016
Study Start
June 1, 2016
Primary Completion
March 1, 2017
Study Completion
June 1, 2017
Last Updated
July 11, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will share