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
  Purpose

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 Intervention
HIV Seropositive
Drug: Rocaltrol
Drug: Vitamin D
Drug: Calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Vitamin D Supplementation to Male HIV Sero-positive Patients

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: April 2008
Study Completion Date: January 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Hvidovre University Hospital

Additional 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
Study First Received: October 6, 2009
Last Updated: September 13, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by 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
Calcitriol
Vitamin D
Ergocalciferols
Vitamins
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014