Clinical trial NCT02351284: Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients
Official title: Impact of Hypovitaminosis D in Metabolic Disturbances and Bone Metabolism, and Changes in Patients Receiving Vitamin D Supplementation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypovitaminosis D
Keywords: HIV, vitamin D, osteoporosis
Lead sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
Sponsor class: NETWORK
First posted: 2015-01-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients in follow up

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of osteopenia/osteoporosis and secondary hyperparathyroidism in HIV infected patients according to vitamin D strata
timeFrame: 48 weeks
Secondary outcomes:
measure: Changes in vitamin D levels secondary to seasonality
timeFrame: 48 weeks
measure: Efficacy of supplementation in reducing secondary hyperparathyroidism and osteopenia/osteoporosis
timeFrame: 48 weeks
measure: Impact of vitamin D levels (25OHD) in reducing phosphaturia levels
timeFrame: 48 weeks
measure: Correlation between values of bone biomarkers (osteocalcin, beta-crosslaps, alkaline phosphatase, P1NP) and rates of osteopenia/osteoporosis
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital
Study officials:
affiliation: Ramon y Cajal Hospital
name: Sara Bañon, MD
role: PRINCIPAL_INVESTIGATOR
References: