Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients
PuraVIHta
Impact of Hypovitaminosis D in Metabolic Disturbances and Bone Metabolism, and Changes in Patients Receiving Vitamin D Supplementation
1 other identifier
observational
300
1 country
1
Brief Summary
To determine the prevalence of hypovitaminosis D in HIV infected patients, and the consequences on secondary hyperparathyroidism, and bone mineral density (BMD). Also, to establish the improvement in vitamin D status, parathyroid hormone (PTH) and BMD, in case of receiving vitamin D supplementation, during a follow up period of at least 1 year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
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
First Submitted
Initial submission to the registry
January 23, 2015
CompletedFirst Posted
Study publicly available on registry
January 30, 2015
CompletedStudy Start
First participant enrolled
January 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 18, 2022
October 1, 2022
3.8 years
January 23, 2015
October 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of osteopenia/osteoporosis and secondary hyperparathyroidism in HIV infected patients according to vitamin D strata
Percentage of patients with high PTH and reduced BMD in each vitamin D strata (\< 10 ng/ml, 10-20 ng/ml, 20-30 ng/ml, \> 30 ng/ml)
48 weeks
Secondary Outcomes (4)
Changes in vitamin D levels secondary to seasonality
48 weeks
Efficacy of supplementation in reducing secondary hyperparathyroidism and osteopenia/osteoporosis
48 weeks
Impact of vitamin D levels (25OHD) in reducing phosphaturia levels
48 weeks
Correlation between values of bone biomarkers (osteocalcin, beta-crosslaps, alkaline phosphatase, P1NP) and rates of osteopenia/osteoporosis
48 weeks
Interventions
Measurement of vitamin D, PTH, and BMD changes in HIV-infected patients
Eligibility Criteria
HIV-infected patients in follow up
You may qualify if:
- HIV older than 18 years
You may not qualify if:
- Chronic kidney disease stage 4 and 5 (creatinine clearance \< 30 ml/min)
- Pregnancy
- Uso of corticosteroid therapy, or requiring anti-resorptive treatment
- Prolonged hospitalization or internment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jose L. Casadolead
Study Sites (1)
Ramon y Cajal Hospital
Madrid, 28034, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Bañon, MD
Ramon y Cajal Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 23, 2015
First Posted
January 30, 2015
Study Start
January 12, 2019
Primary Completion
November 1, 2022
Study Completion
December 1, 2022
Last Updated
October 18, 2022
Record last verified: 2022-10