Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT01295034
Eligibility Criteria:
Inclusion Criteria:
* age, 18-70 yr
* HIV-infected
* on a stable HAART regimen for at least 12 mo with an undetectable HIV viral load for 6-mo
* willing to participate
* not receiving vitamin D supplementation in a form other than vitamin D2 or vitamin D3
* not receiving treatment for bone disease
* not receiving medications known to alter bone mineralization
* not suffering from conditions known to affect vitamin D, calcium, and/or phosphate levels (including clinically significant hypocalcemia, primary hyperparathyroidism)
* not experiencing kidney disease based on GFR \> 60 min/ml/1.73 m2, 10) 25(OH)D level \< 25 ng/ml
* not meeting criteria of the National Osteoporosis Foundation for established bone disease (osteoporosis, osteomalacia) requiring immediate treatment
* not consuming more than 2.0 gm of calcium/day in food and supplements combined outside the trial
* not consuming more than 800IU/day of vitamin D outside the trial
* not suffering from an unstable medical condition likely to preclude participation in a 12 month trial
* able to ingest and absorb food and nutrients
* not pregnant or planning to become pregnant.
Exclusion Criteria:
* No history or evidence of HIV infection
* HIV viral load positive
* outside the age range
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01295034
Study Brief:
Protocol Section:
NCT01295034