Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Hypovitaminosis D

Intervention / Treatment
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* Other: Measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measurement|Measurement of vitamin D, PTH, and BMD changes in HIV-infected patients|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, vitamin D, osteoporosis