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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-005039-40 | |||
| Danish Health 2612-3303 |
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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):
The endpoints are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Strong vitamin D" | Experimental | Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily |
|
| Vitamin D | Active Comparator | calcium 400 mg + 10 microgram Vitamin D3, 3 times daily |
|
| Calcium | Placebo Comparator | Tablet Calcium 400 mg x 3 daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocaltrol | Drug | tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| serum-vitamin D metabolites | week 0 | |
| serum-vitamin D metabolites | week 2 | |
| serum-vitamin D metabolites | week 4 | |
| serum-vitamin D metabolites | week 8 | |
| serum-vitamin D metabolites | week 12 | |
| serum-vitamin D metabolites | week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| T-lymphocyte fractions Parathyroid hormone ionized calcium | week 0 | |
| T-lymphocyte fractions Parathyroid hormone ionized calcium | week 2 | |
| T-lymphocyte fractions Parathyroid hormone ionized calcium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich C Bang, M.D. | Dept. of Endocrinology, Hvidovre Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of endocrinology, Hvidovre Hospital | Copenhagen | 2450 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22592096 | Derived | 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. |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| D014807 | Vitamin D |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| Vitamin D |
| Drug |
tablets, vitamin D3, 30 microgram daily |
|
| Calcium | Drug | tablets, 400 mg calcium, 3 times daily |
|
| week 4 |
| T-lymphocyte fractions Parathyroid hormone ionized calcium | week 8 |
| T-lymphocyte fractions Parathyroid hormone ionized calcium | week 12 |
| T-lymphocyte fractions Parathyroid hormone ionized calcium | week 16 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |