Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients

Hypovitaminosis D Clinical Trial

— PuraVIHta  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02351284
• Other study ID #: 20/15
• Status: Recruiting
• Start date: January 12, 2019
• Est. completion date: December 2022

Study information

• Verified date: October 2022
• Source: Asociacion para el Estudio de las Enfermedades Infecciosas
• Contact: Jose L Casado, MD
• Phone: 34913368672
• Email: jcasado.hrc[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Intervention

Other:
• Measurement
Measurement of vitamin D, PTH, and BMD changes in HIV-infected patients

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Jose L. Casado

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in vitamin D levels secondary to seasonality	Changes in 25-hydroxy vitamin D according to season	48 weeks
Secondary	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
Secondary	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
Secondary	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