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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02351284
Recruitment Status : Recruiting
First Posted : January 30, 2015
Last Update Posted : August 25, 2020
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.

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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
Actual Study Start Date : January 12, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT02351284

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Contact: Jose L Casado, MD 34913368672

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Ramon y Cajal Hospital Recruiting
Madrid, Spain, 28034
Contact: Jose L Casado, MD    34913368672   
Principal Investigator: Jose L Casado, MD         
Sponsors and Collaborators
Jose L. Casado
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Principal Investigator: Sara Bañon, MD Ramon y Cajal Hospital
Additional Information:

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Responsible Party: Jose L. Casado, MD, PhD, Asociacion para el Estudio de las Enfermedades Infecciosas Identifier: NCT02351284    
Other Study ID Numbers: 20/15
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Keywords provided by Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas:
HIV, vitamin D, osteoporosis
Additional relevant MeSH terms:
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Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders