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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement | Other | Measurement of vitamin D, PTH, and BMD changes in HIV-infected patients |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected patients in follow up
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose L Casado, MD | Contact | 34913368672 | jcasado.hrc@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Sara BaƱon, MD | Ramon y Cajal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramon y Cajal Hospital | Recruiting | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |