Clinical Trial: Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

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

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 Summary:

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.


Sponsor: Jose L. Casado

Current Primary Outcome: Prevalence of osteopenia/osteoporosis and secondary hyperparathyroidism in HIV infected patients according to vitamin D strata [ Time Frame: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in vitamin D levels secondary to seasonality [ Time Frame: 48 weeks ]
    Changes in 25-hydroxy vitamin D according to season
  • Efficacy of supplementation in reducing secondary hyperparathyroidism and osteopenia/osteoporosis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 48 weeks ]
    To establish baseline values and relationship of bone biomarkers with bone mineral density status, adjusted by vitamin D strata


Original Secondary Outcome: Same as current

Information By: Asociacion para el Estudio de las Enfermedades Infecciosas

Dates:
Date Received: January 23, 2015
Date Started: June 2016
Date Completion: March 2018
Last Updated: July 19, 2016
Last Verified: July 2016