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Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients (PuraVIHta)

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ClinicalTrials.gov Identifier: NCT02351284
Recruitment Status : Not yet recruiting
First Posted : January 30, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas

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.

Condition or disease Intervention/treatment
Hypovitaminosis D Other: Measurement

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Impact of Hypovitaminosis D in Metabolic Disturbances and Bone Metabolism, and Changes in Patients Receiving Vitamin D Supplementation
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018



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


Primary Outcome Measures :
  1. Prevalence of osteopenia/osteoporosis and secondary hyperparathyroidism in HIV infected patients according to vitamin D strata [ Time Frame: 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 Outcome Measures :
  1. Changes in vitamin D levels secondary to seasonality [ Time Frame: 48 weeks ]
    Changes in 25-hydroxy vitamin D according to season

  2. Efficacy of supplementation in reducing secondary hyperparathyroidism and osteopenia/osteoporosis [ Time Frame: 48 weeks ]
    Changes in PTH and BMD (% of patients having secondary hyperparathyroidism and osteopenia/osteoporosis) after receiving vitamin D supplementation according to clinical decision

  3. Impact of vitamin D levels (25OHD) in reducing phosphaturia levels [ Time Frame: 48 weeks ]
    Improvement in phosphaturia levels (elemental urine) according to vitamin D strata and/or supplementation

  4. Correlation between values of bone biomarkers (osteocalcin, beta-crosslaps, alkaline phosphatase, P1NP) and rates of osteopenia/osteoporosis [ Time Frame: 48 weeks ]
    To establish baseline values and relationship of bone biomarkers with bone mineral density status, adjusted by vitamin D strata



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected patients in follow up
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351284


Contacts
Contact: Jose L Casado, MD 34913368672 jcasado.hrc@salud.madrid.org

Locations
Spain
Ramon y Cajal Hospital Active, not recruiting
Madrid, Spain, 28034
Sponsors and Collaborators
Jose L. Casado
Investigators
Principal Investigator: Sara Bañon, MD Ramon y Cajal Hospital

Responsible Party: Jose L. Casado, MD, PhD, Asociacion para el Estudio de las Enfermedades Infecciosas
ClinicalTrials.gov Identifier: NCT02351284     History of Changes
Other Study ID Numbers: 20/15
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas:
HIV, vitamin D, osteoporosis

Additional relevant MeSH terms:
Rickets
Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamins
Vitamin D
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents