Overview

This trial is active, not recruiting.

Condition hypovitaminosis d
Treatment measurement
Sponsor Jose L. Casado
Start date June 2016
End date January 2018
Trial size 300 participants
Trial identifier NCT02351284, 20/15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Prevalence of osteopenia/osteoporosis and secondary hyperparathyroidism in HIV infected patients according to vitamin D strata
time frame: 48 weeks

Secondary Outcomes

Measure
Changes in vitamin D levels secondary to seasonality
time frame: 48 weeks
Efficacy of supplementation in reducing secondary hyperparathyroidism and osteopenia/osteoporosis
time frame: 48 weeks
Impact of vitamin D levels (25OHD) in reducing phosphaturia levels
time frame: 48 weeks
Correlation between values of bone biomarkers (osteocalcin, beta-crosslaps, alkaline phosphatase, P1NP) and rates of osteopenia/osteoporosis
time frame: 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Impact of Hypovitaminosis D in Metabolic Disturbances and Bone Metabolism, and Changes in Patients Receiving Vitamin D Supplementation
Principal investigator Sara Bañon, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Asociacion para el Estudio de las Enfermedades Infecciosas.