Loading clinical trials...
Loading clinical trials...
Impact of Hypovitaminosis D in Metabolic Disturbances and Bone Metabolism, and Changes in Patients Receiving Vitamin D Supplementation
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ramon y Cajal Hospital
Madrid, Spain
Start Date
January 12, 2019
Primary Completion Date
November 1, 2022
Completion Date
December 1, 2022
Last Updated
October 18, 2022
300
ESTIMATED participants
Measurement
OTHER
Lead Sponsor
Jose L. Casado
NCT06138249
NCT07199829
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07096414