Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients

Recruiting

• Conditions: Hypovitaminosis D

• Registration Number: NCT02351284
• Lead Sponsor: Jose L. Casado

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.

Detailed Description

This study deals with the impact of vitamin D on metabolism and bone health in HIV infected patients. To answer the questions about the importance of this hormone in this population, we designed a cohort study about the prevalence of vitamin D deficiency (measured as 25-hydroxy-vitamin D), classifying it in severe deficiency (\<10 ng/ml), deficiency (\< 20 ng/ml), or insufficiency (\< 30 ng/ml), the relationship with secondary hyperparathyroidism (PTH \> 65 pg/ml), and related BMD by dual X-ray absorptiometry (DXA). These results will be adjusted by baseline factors, such as age, gender, body mass index (BMI), hepatitis C virus (HCV) coinfection, risk practice for HIV infection, CD4+ count, antiretroviral therapy, and HIV RNA level.

In patients receiving vitamin D supplementation according to clinical decision, it will be evaluated the changes in percentage of hypovitaminosis D and/or secondary hyperparathyroidism, and the effect on BMD. Bone biomarkers will be collected to determine the impact of changes secondary to vitamin D improvement in the bone evolution.

Study Timeline

• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-30
• Study Start: 2019-01-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-18
• Primary Completion: 2022-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• HIV older than 18 years

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of osteopenia/osteoporosis and secondary hyperparathyroidism in HIV infected patients according to vitamin D strata	48 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Changes in vitamin D levels secondary to seasonality	48 weeks	Changes in 25-hydroxy vitamin D according to season
Efficacy of supplementation in reducing secondary hyperparathyroidism and osteopenia/osteoporosis	48 weeks	Changes in PTH and BMD (% of patients having secondary hyperparathyroidism and osteopenia/osteoporosis) after receiving vitamin D supplementation according to clinical decision
Impact of vitamin D levels (25OHD) in reducing phosphaturia levels	48 weeks	Improvement in phosphaturia levels (elemental urine) according to vitamin D strata and/or supplementation
Correlation between values of bone biomarkers (osteocalcin, beta-crosslaps, alkaline phosphatase, P1NP) and rates of osteopenia/osteoporosis	48 weeks	To establish baseline values and relationship of bone biomarkers with bone mineral density status, adjusted by vitamin D strata

Trial Locations

Locations (1)

Ramon y Cajal Hospital; 🇪🇸 Madrid, Spain