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

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Jose L. Casado
Updated on 1 February 2023
vitamin d supplementation
parathyroid
vitamin
vitamins
bone mineral density
parathyroid hormone
hyperparathyroidism
bone disorder
rickets
hypovitaminosis

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.

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.

Details
Condition Hypovitaminosis D
Treatment Measurement
Clinical Study IdentifierNCT02351284
SponsorJose L. Casado
Last Modified on1 February 2023

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