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Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00490412
First received: June 21, 2007
Last updated: May 15, 2014
Last verified: May 2014

June 21, 2007
May 15, 2014
December 2007
January 2010   (final data collection date for primary outcome measure)
  • To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover. [ Time Frame: Baseline, Week 4, Week 12 ] [ Designated as safety issue: Yes ]
  • To measure the safety of 50,000 IU dose of vitamin D3 [ Time Frame: Baseline, Week 4, and Week 8 ] [ Designated as safety issue: Yes ]
  • To compare the change in renal tubular reabsorption of phosphate and markers of bone turn
  • To measure the safety of 50,000 IU dose of vitamin D3
Complete list of historical versions of study NCT00490412 on ClinicalTrials.gov Archive Site
  • To measure the relationship of vitamin D plasma concentrations to renal tubular reabsorption of phosphate and markers of bone turnover [ Time Frame: Baseline, Week 4, and Week 12 ] [ Designated as safety issue: Yes ]
  • To measure the relationship of tenofovir exposure to renal tubular reabsorption of phosphate and markers of bone turnover [ Time Frame: Baseline, Week 4, and Week 12 ] [ Designated as safety issue: Yes ]
  • To measure the change in tenofovir exposure and creatinine clearance [ Time Frame: Baseline, Week 4, and Week 12 ] [ Designated as safety issue: Yes ]
  • To measure the relationship of vitamin D plasma concentrations to renal tubular reabsorption of phosphate and markers of bone turnover
  • To measure the relationship of tenofovir exposure to renal tubular reabsorption of phosphate and markers of bone turnover
  • To measure the change in tenofovir exposure and creatinine clearance
Not Provided
Not Provided
 
Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection
Randomized, Placebo-controlled Trial of the Safety and Effectiveness of Vitamin D Supplement to Improve Tubular Reabsorption of Phosphate and Decrease Bone Turnover in Adolescents and Young Adults With HIV Infection Being Treated With Antiretroviral Therapy Containing Tenofovir Compared to Those Being Treated With Antiretroviral Therapy Not Containing Tenofovir

The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone loss, which are common in HIV infected adolescents and young adults being treated with tenofovir.

ATN 063 tests the hypothesis that in a population of adolescents and young adults with HIV infection who are being treated with tenofovir as part of an antiretroviral (ARV) combination regimen, vitamin D supplementation will decrease renal phosphate loss, increase plasma phosphate, decrease plasma PTH, and improve markers of bone turnover, including a decrease in plasma N-telopeptide and BAP.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV Infections
  • Dietary Supplement: Vitamin D supplement
    Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
  • Other: Placebo
    A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
  • Experimental: A: tenofovir/vitamin D
    Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group A (who are already taking Tenofovir) once every four weeks during study visits.
    Intervention: Dietary Supplement: Vitamin D supplement
  • Placebo Comparator: B: tenofovir/placebo
    A placebo will be administered orally to subjects in Group B (who are already taking Tenofovir).
    Intervention: Other: Placebo
  • Experimental: C: no tenofovir/vitamin D
    Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group C (who are not taking Tenofovir) once every four weeks during study visits.
    Intervention: Dietary Supplement: Vitamin D supplement
  • Placebo Comparator: D: no tenofovir/placebo
    A placebo will be administered orally to subjects in Group D (who are not taking Tenofovir).
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years and 0 days through 24 years and 364 days
  • HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry
  • Currently being treated with a stable FDA-approved ARV combination therapy, containing > 3 antiretrovirals, for > 28 days, according to HRSA guidelines. Treatment regimen will not be started or changed for the purposes of participation in this study. Subjects will be receiving therapy at the direction of their treating physician
  • Willingness to remain on the same ARV combination therapy for the 12-week duration of the study
  • Ability and willingness to participate in the study by providing written informed consent
  • Willingness to be randomized to receive either vitamin D or placebo

Exclusion Criteria:

  • Prior hypersensitivity to vitamin D
  • History of arteriosclerosis, renal stones, glomerulonephritis, nephrotic syndrome, or hypercalcemia
  • Lactation or current pregnancy
  • Active therapy for malignancy
  • Known presence of gastrointestinal disease that would interfere with drug administration or absorption
  • Serological evidence of Hepatitis B surface antigen (HBsAg)
  • Confirmed creatinine clearance < 90 ml/min (calculated GFR from serum creatinine using the MDRD formula)
  • Grade 3 or higher clinical toxicity
Both
18 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00490412
ATN 063
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Peter L Havens, M.S., M.D. Medical College of Wisconsin
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP