Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2021-06-30
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Vitamin D (600 IU)
Vitamin D (600 IU)
Daily oral dose for 12 months
Vitamin D (2000 IU)
Vitamin D (2000 IU)
Daily oral dose for 12 months
Vitamin D (4000 IU)
Vitamin D (4000 IU)
Daily oral dose for 12 months
Placebo
Placebo
Daily oral dose for 12 months
Interventions
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Vitamin D (600 IU)
Daily oral dose for 12 months
Vitamin D (2000 IU)
Daily oral dose for 12 months
Vitamin D (4000 IU)
Daily oral dose for 12 months
Placebo
Daily oral dose for 12 months
Eligibility Criteria
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Inclusion Criteria
* HIV infection status (according to AMC HIV clinic medical records of enzyme-linked immunosorbent assay \[ELISA\] results)
Exclusion Criteria
* 60 years of age
* Pregnant at baseline
* Other severe complications or illnesses requiring hospitalization
* Received TB treatment for greater than 4 weeks in the past 5 years
* Refused to participate
* Residing in a geographic location \> 1 hour from AMC (by public transit)
18 Years
60 Years
ALL
No
Sponsors
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Arogyavaram Medical Centre
OTHER
Cornell University
OTHER
Responsible Party
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Principal Investigators
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Saurabh Mehta, MBBS, ScD
Role: PRINCIPAL_INVESTIGATOR
Cornell University (U.S.)
Wesley Bonam, BSc, MBBS, FAIMS, MRSH
Role: PRINCIPAL_INVESTIGATOR
Arogyavaram Medical Centre (India)
Locations
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Cornell University
Ithaca, New York, United States
Arogyavaram Medical Centre (AMC)
Madanapalle, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB #: 1304003801
Identifier Type: -
Identifier Source: org_study_id
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