Hypovitaminosis D
Conditions
Keywords
HIV, vitamin D, osteoporosis
Brief 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.
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.
Interventions
OTHERMeasurement
Measurement of vitamin D, PTH, and BMD changes in HIV-infected patients
Sponsors
Jose L. Casado
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of osteopenia/osteoporosis and secondary hyperparathyroidism in HIV infected patients according to vitamin D strata | 48 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in vitamin D levels secondary to seasonality | 48 weeks | Changes in 25-hydroxy vitamin D according to season |
| Efficacy of supplementation in reducing secondary hyperparathyroidism and osteopenia/osteoporosis | 48 weeks | Changes in PTH and BMD (% of patients having secondary hyperparathyroidism and osteopenia/osteoporosis) after receiving vitamin D supplementation according to clinical decision |
| Impact of vitamin D levels (25OHD) in reducing phosphaturia levels | 48 weeks | Improvement in phosphaturia levels (elemental urine) according to vitamin D strata and/or supplementation |
| Correlation between values of bone biomarkers (osteocalcin, beta-crosslaps, alkaline phosphatase, P1NP) and rates of osteopenia/osteoporosis | 48 weeks | To establish baseline values and relationship of bone biomarkers with bone mineral density status, adjusted by vitamin D strata |
Countries
Spain
Contacts
Primary ContactJose L Casado, MD
Outcome results
None listed