Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients (PuraVIHta)

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.

Study Overview

• Status: Recruiting
• Conditions: Hypovitaminosis D
• Intervention / Treatment: Other: Measurement

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Jose L Casado, MD; Phone Number: 34913368672; Email: jcasado.hrc@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Ramón y Cajal Hospital
    • Contact: Jose L Casado, MD; Phone Number: 34913368672; Email: jcasado.hrc@gmail.com
    • Principal Investigator: Jose L Casado, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients in follow up

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of osteopenia/osteoporosis and secondary hyperparathyroidism in HIV infected patients according to vitamin D strata	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)	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in vitamin D levels secondary to seasonality	Changes in 25-hydroxy vitamin D according to season	48 weeks
Efficacy of supplementation in reducing secondary hyperparathyroidism and osteopenia/osteoporosis	Changes in PTH and BMD (% of patients having secondary hyperparathyroidism and osteopenia/osteoporosis) after receiving vitamin D supplementation according to clinical decision	48 weeks
Impact of vitamin D levels (25OHD) in reducing phosphaturia levels	Improvement in phosphaturia levels (elemental urine) according to vitamin D strata and/or supplementation	48 weeks
Correlation between values of bone biomarkers (osteocalcin, beta-crosslaps, alkaline phosphatase, P1NP) and rates of osteopenia/osteoporosis	To establish baseline values and relationship of bone biomarkers with bone mineral density status, adjusted by vitamin D strata	48 weeks

Collaborators and Investigators

• Sponsor: Jose L. Casado
• Investigators: Principal Investigator: Sara Bañon, MD, Ramón y Cajal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2019
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: HIV, vitamin D, osteoporosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Musculoskeletal Diseases; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Vitamin D Deficiency; Rickets; Avitaminosis
• Other Study ID Numbers: 20/15