NCT02351284

Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients

Impact of Hypovitaminosis D in Metabolic Disturbances and Bone Metabolism, and Changes in Patients Receiving Vitamin D Supplementation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Jose L. Casado · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypovitaminosis D

Interventions

Type	Name	Description
OTHER	Measurement	Measurement of vitamin D, PTH, and BMD changes in HIV-infected patients

Timeline

• Start date: 2019-01-12
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2015-01-30
• Last updated: 2022-10-18

Locations

1 site across 1 country: Spain