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

Primary Purpose

HIV Seropositive

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Rocaltrol

Vitamin D

Calcium

About this trial

This is an interventional treatment trial for HIV Seropositive focused on measuring HIV-1, humans, vitamin D, 1-hydroxy-vitamin D, Rocaltrol, calcium, complementary therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Dept. of endocrinology, Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

"Strong vitamin D"

Vitamin D

Calcium

Arm Description

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

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

Tablet Calcium 400 mg x 3 daily

Outcomes

Primary Outcome Measures

serum-vitamin D metabolites

Secondary Outcome Measures

T-lymphocyte fractions Parathyroid hormone ionized calcium

Full Information

NCT ID

NCT00990678

First Posted

October 6, 2009

Last Updated

September 13, 2012

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00990678

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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): Calcium Calcium and 25-hydroxy-vitamin D 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Seropositive

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

"Strong vitamin D"

Arm Type

Experimental

Arm Description

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

Arm Title

Vitamin D

Arm Type

Active Comparator

Arm Description

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

Arm Title

Calcium

Arm Type

Placebo Comparator

Arm Description

Tablet Calcium 400 mg x 3 daily

Intervention Type

Drug

Intervention Name(s)

Rocaltrol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Intervention Description

tablets, vitamin D3, 30 microgram daily

Intervention Type

Drug

Intervention Name(s)

Calcium

Intervention Description

tablets, 400 mg calcium, 3 times daily

Primary Outcome Measure Information:

Title

serum-vitamin D metabolites

Time Frame

week 0

Title

serum-vitamin D metabolites

Time Frame

week 2

Title

serum-vitamin D metabolites

Time Frame

week 4

Title

serum-vitamin D metabolites

Time Frame

week 8

Title

serum-vitamin D metabolites

Time Frame

week 12

Title

serum-vitamin D metabolites

Time Frame

week 16

Secondary Outcome Measure Information:

Title

T-lymphocyte fractions Parathyroid hormone ionized calcium

Time Frame

week 0

Title

T-lymphocyte fractions Parathyroid hormone ionized calcium

Time Frame

week 2

Title

T-lymphocyte fractions Parathyroid hormone ionized calcium

Time Frame

week 4

Title

T-lymphocyte fractions Parathyroid hormone ionized calcium

Time Frame

week 8

Title

T-lymphocyte fractions Parathyroid hormone ionized calcium

Time Frame

week 12

Title

T-lymphocyte fractions Parathyroid hormone ionized calcium

Time Frame

week 16

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrich C Bang, M.D.

Organizational Affiliation

Dept. of Endocrinology, Hvidovre Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of endocrinology, Hvidovre Hospital

City

Copenhagen

ZIP/Postal Code

2450

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

22592096

Citation

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.

Results Reference

derived

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

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