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

NCT ID: NCT00990678

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-01-31

Brief Summary

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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)

Detailed Description

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Conditions

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HIV Seropositive

Keywords

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HIV-1 humans vitamin D 1-hydroxy-vitamin D Rocaltrol calcium complementary therapies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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"Strong vitamin D"

Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily

Group Type EXPERIMENTAL

Rocaltrol

Intervention Type DRUG

tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily

Vitamin D

Intervention Type DRUG

tablets, vitamin D3, 30 microgram daily

Calcium

Intervention Type DRUG

tablets, 400 mg calcium, 3 times daily

Vitamin D

calcium 400 mg + 10 microgram Vitamin D3, 3 times daily

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

tablets, vitamin D3, 30 microgram daily

Calcium

Intervention Type DRUG

tablets, 400 mg calcium, 3 times daily

Calcium

Tablet Calcium 400 mg x 3 daily

Group Type PLACEBO_COMPARATOR

Calcium

Intervention Type DRUG

tablets, 400 mg calcium, 3 times daily

Interventions

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Rocaltrol

tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily

Intervention Type DRUG

Vitamin D

tablets, vitamin D3, 30 microgram daily

Intervention Type DRUG

Calcium

tablets, 400 mg calcium, 3 times daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulrich Bang

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrich C Bang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Endocrinology, Hvidovre Hospital

Locations

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Dept. of endocrinology, Hvidovre Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 22592096 (View on PubMed)

Other Identifiers

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EudraCT 2006-005039-40

Identifier Type: -

Identifier Source: secondary_id

Danish Health 2612-3303

Identifier Type: -

Identifier Source: secondary_id

HH-JEBJ-HIVstudy

Identifier Type: -

Identifier Source: org_study_id