HIV SeropositiveNCT00990678
Study of Vitamin D Supplementation to Male HIV Sero-positive Patients
A study testing Rocaltrol, Vitamin D and Calcium in people with HIV Seropositive, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositive
- What is being tested?
- Rocaltrol, Vitamin D and Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- HIV-positive
- at least 18 years old
- receiving HiglyActiveAntiRetroviral Therapy (HAART)
Who cannot join
- hypercalcemia
- tuberculosis
- osteoporosis or other bone disease
- cancer with bone metastasis
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- HIV Seropositive
- Being tested
- Rocaltrol, Vitamin D, Calcium
- Keywords
- HIV-1, humans, vitamin D, 1-hydroxy-vitamin D, Rocaltrol, calcium, complementary therapies
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocaltrolDrug
tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily
Vitamin DDrug
tablets, vitamin D3, 30 microgram daily
CalciumDrug
tablets, 400 mg calcium, 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| "Strong vitamin D" | Experimental | Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily Receives: Drug: Rocaltrol; Drug: Vitamin D; Drug: Calcium |
| Vitamin D | Active comparator | calcium 400 mg + 10 microgram Vitamin D3, 3 times daily Receives: Drug: Vitamin D; Drug: Calcium |
| Calcium | Placebo comparator | Tablet Calcium 400 mg x 3 daily Receives: Drug: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum-vitamin D metabolites
Measured: week 0
serum-vitamin D metabolites
Measured: week 2
serum-vitamin D metabolites
Measured: week 4
serum-vitamin D metabolites
Measured: week 8
serum-vitamin D metabolites
Measured: week 12
serum-vitamin D metabolites
Measured: week 16
Secondary outcomes (6)
T-lymphocyte fractions Parathyroid hormone ionized calcium
Measured: week 0
T-lymphocyte fractions Parathyroid hormone ionized calcium
Measured: week 2
T-lymphocyte fractions Parathyroid hormone ionized calcium
Measured: week 4
T-lymphocyte fractions Parathyroid hormone ionized calcium
Measured: week 8
T-lymphocyte fractions Parathyroid hormone ionized calcium
Measured: week 12
T-lymphocyte fractions Parathyroid hormone ionized calcium
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startApr 2008
- Primary completionFeb 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrich Bang, Hvidovre University Hospital
- Investigators
- Ulrich C Bang, M.D., Principal investigator, Dept. of Endocrinology, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990678
- Sponsor's protocol ID
- HH-JEBJ-HIVstudy
- Other IDs
- EudraCT 2006-005039-40, Danish Health 2612-3303
- Status last verified
- Sep 2012
- First submitted
- 6 Oct 2009
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22592096
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Vitamin D Supplementation to Male HIV Sero-positive Patients
- ClinicalTrials.gov ID
- NCT00990678
- Acronym / sponsor ID
- HH-JEBJ-HIVstudy
- Conditions
- HIV Seropositive
- Keywords
- HIV-1, humans, vitamin D, 1-hydroxy-vitamin D, Rocaltrol, calcium, complementary therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Strong vitamin D" | Experimental | Drug: Rocaltrol, Drug: Vitamin D, Drug: CalciumCalcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily |
| Vitamin D | Active comparator | Drug: Vitamin D, Drug: Calciumcalcium 400 mg + 10 microgram Vitamin D3, 3 times daily |
| Calcium | Placebo comparator | Drug: CalciumTablet Calcium 400 mg x 3 daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male
- HIV-positive
- at least 18 years old
- receiving HiglyActiveAntiRetroviral Therapy (HAART)
Key exclusion criteria (4 listed)
- hypercalcemia
- tuberculosis
- osteoporosis or other bone disease
- cancer with bone metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocaltroltablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily | Drug | "Strong vitamin D" |
| Vitamin Dtablets, vitamin D3, 30 microgram daily | Drug | "Strong vitamin D", Vitamin D |
| Calciumtablets, 400 mg calcium, 3 times daily | Drug | "Strong vitamin D", Calcium, Vitamin D |
Primary outcome
serum-vitamin D metabolites
Time frame: week 0
serum-vitamin D metabolites
Time frame: week 2
serum-vitamin D metabolites
Time frame: week 4
serum-vitamin D metabolites
Time frame: week 8
serum-vitamin D metabolites
Time frame: week 12
serum-vitamin D metabolites
Time frame: week 16
6 secondary outcomes
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time frame: week 0
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time frame: week 2
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time frame: week 4
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time frame: week 8
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time frame: week 12
T-lymphocyte fractions Parathyroid hormone ionized calcium
Time frame: week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
- Derived from this study: PubMed 22592096Bang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich C Bang, M.D. principal investigator
Dept. of Endocrinology, Hvidovre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocaltrol, Vitamin D and Calcium in people with HIV Seropositive, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum-vitamin D metabolites (time frame: week 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00990678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2012.