Study of Vitamin D Supplementation to Male HIV Sero-positive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrich Bang, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00990678
First received: October 6, 2009
Last updated: September 13, 2012
Last verified: September 2012

October 6, 2009
September 13, 2012
April 2008
February 2010   (final data collection date for primary outcome measure)
  • serum-vitamin D metabolites [ Time Frame: week 0 ] [ Designated as safety issue: Yes ]
  • serum-vitamin D metabolites [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
  • serum-vitamin D metabolites [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
  • serum-vitamin D metabolites [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
  • serum-vitamin D metabolites [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • serum-vitamin D metabolites [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00990678 on ClinicalTrials.gov Archive Site
  • T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 0 ] [ Designated as safety issue: Yes ]
  • T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
  • T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
  • T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
  • T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of Vitamin D Supplementation to Male HIV Sero-positive Patients
Study of Vitamin D Supplementation to Male HIV Sero-positive Patients

The investigators want to investigate if HIV sero-positive males benefit from vitamin D supplementation. The study runs in 16 weeks and the participants are treated with one of three placebo controlled regimes (tablets):

  1. Calcium
  2. Calcium and 25-hydroxy-vitamin D
  3. Calcium and 25-hydroxy-vitamin D and 1,25-dihydroxyvitamin D

The endpoints are:

  • Serum vitamin D
  • Parathyroid hormone
  • ionized calcium
  • T-lymphocyte fractions (naïve, mature, Tregs)
  • Osteocalcin (bone metabolism)
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Seropositive
  • Drug: Rocaltrol
    tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily
  • Drug: Vitamin D
    tablets, vitamin D3, 30 microgram daily
  • Drug: Calcium
    tablets, 400 mg calcium, 3 times daily
  • Experimental: "Strong vitamin D"
    Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily
    Interventions:
    • Drug: Rocaltrol
    • Drug: Vitamin D
    • Drug: Calcium
  • Active Comparator: Vitamin D
    calcium 400 mg + 10 microgram Vitamin D3, 3 times daily
    Interventions:
    • Drug: Vitamin D
    • Drug: Calcium
  • Placebo Comparator: Calcium
    Tablet Calcium 400 mg x 3 daily
    Intervention: Drug: Calcium
Bang U, Kolte L, Hitz M, Dam Nielsen S, Schierbeck LL, Andersen O, Haugaard SB, Mathiesen L, Benfield T, Jensen JE. Correlation of increases in 1,25-dihydroxyvitamin D during vitamin D therapy with activation of CD4+ T lymphocytes in HIV-1-infected males. HIV Clin Trials. 2012 May-Jun;13(3):162-70. doi: 10.1310/hct1303-162.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2011
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male
  • HIV-positive
  • at least 18 years old
  • receiving HiglyActiveAntiRetroviral Therapy (HAART)

Exclusion Criteria:

  • hypercalcemia
  • tuberculosis
  • osteoporosis or other bone disease
  • cancer with bone metastasis
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00990678
HH-JEBJ-HIVstudy, EudraCT 2006-005039-40, Danish Health 2612-3303
Yes
Ulrich Bang, Hvidovre University Hospital
Hvidovre University Hospital
Not Provided
Principal Investigator: Ulrich C Bang, M.D. Dept. of Endocrinology, Hvidovre Hospital
Hvidovre University Hospital
September 2012

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