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

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ClinicalTrials.gov Identifier: NCT00990678
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : September 17, 2012
Sponsor:
Information provided by (Responsible Party):
Ulrich Bang, Hvidovre University Hospital

Brief Summary:

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)

Condition or disease Intervention/treatment Phase
HIV Seropositive Drug: Rocaltrol Drug: Vitamin D Drug: Calcium Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Vitamin D Supplementation to Male HIV Sero-positive Patients
Study Start Date : April 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Experimental: "Strong vitamin D"
Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily
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
Active Comparator: Vitamin D
calcium 400 mg + 10 microgram Vitamin D3, 3 times daily
Drug: Vitamin D
tablets, vitamin D3, 30 microgram daily
Drug: Calcium
tablets, 400 mg calcium, 3 times daily
Placebo Comparator: Calcium
Tablet Calcium 400 mg x 3 daily
Drug: Calcium
tablets, 400 mg calcium, 3 times daily



Primary Outcome Measures :
  1. serum-vitamin D metabolites [ Time Frame: week 0 ]
  2. serum-vitamin D metabolites [ Time Frame: week 2 ]
  3. serum-vitamin D metabolites [ Time Frame: week 4 ]
  4. serum-vitamin D metabolites [ Time Frame: week 8 ]
  5. serum-vitamin D metabolites [ Time Frame: week 12 ]
  6. serum-vitamin D metabolites [ Time Frame: week 16 ]

Secondary Outcome Measures :
  1. T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 0 ]
  2. T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 2 ]
  3. T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 4 ]
  4. T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 8 ]
  5. T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 12 ]
  6. T-lymphocyte fractions Parathyroid hormone ionized calcium [ Time Frame: week 16 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT00990678


Locations
Denmark
Dept. of endocrinology, Hvidovre Hospital
Copenhagen, Denmark, 2450
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Ulrich C Bang, M.D. Dept. of Endocrinology, Hvidovre Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrich Bang, M.D., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00990678     History of Changes
Other Study ID Numbers: HH-JEBJ-HIVstudy
EudraCT 2006-005039-40
Danish Health 2612-3303
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by Ulrich Bang, Hvidovre University Hospital:
HIV-1
humans
vitamin D
1-hydroxy-vitamin D
Rocaltrol
calcium
complementary therapies

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcitriol
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents