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

September 13, 2012 updated by: Ulrich Bang, Hvidovre University Hospital

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2450
        • Dept. of Endocrinology, Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum-vitamin D metabolites
Time Frame: week 0
week 0
serum-vitamin D metabolites
Time Frame: week 2
week 2
serum-vitamin D metabolites
Time Frame: week 4
week 4
serum-vitamin D metabolites
Time Frame: week 8
week 8
serum-vitamin D metabolites
Time Frame: week 12
week 12
serum-vitamin D metabolites
Time Frame: week 16
week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time Frame: week 0
week 0
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time Frame: week 2
week 2
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time Frame: week 4
week 4
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time Frame: week 8
week 8
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time Frame: week 12
week 12
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time Frame: week 16
week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Ulrich C Bang, M.D., Dept. of Endocrinology, Hvidovre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

October 6, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (ESTIMATE)

October 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HH-JEBJ-HIVstudy
  • EudraCT 2006-005039-40
  • Danish Health 2612-3303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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