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.
Study Type
OBSERVATIONAL
Enrollment
300
Measurement of vitamin D, PTH, and BMD changes in HIV-infected patients
Ramon y Cajal Hospital
Madrid, Spain
RECRUITINGPrevalence 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)
Time frame: 48 weeks
Changes in vitamin D levels secondary to seasonality
Changes in 25-hydroxy vitamin D according to season
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48 weeks
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