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| Name | Class |
|---|---|
| IPS Fundación SIAM | UNKNOWN |
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INTRODUCTION:
An adequate zinc supplementation is essential for a good immunological function. However, zinc deficiency is seen in more than 50% of adults infected with HIV. The safety and efficiency of zinc supplements in the progression of HIV is evaluated in the short-term.
HYPOTHESIS
Null hypothesis: Zinc supplementation does not improve the immunological recovery of HIV patients after three months of daily consumption.
Alternate hypothesis: Zinc supplementation improves the immunological recovery of HIV patients after three months of daily consumption
GOAL:
To assess the effect of zinc supplementation in the natural history of HIV, emphasizing on the immunological recovery of patients in a health care provider program in MedellÃn in 2012.
METHODS:
A prospective, randomized, double-blind, controlled clinical trial will be conducted. The selected group will consist of male and female patients over 18 years of age, who comply with the inclusion criteria, with digital clinical history, in an HIV/AIDS program of a health care provider in MedellÃn. They will receive zinc supplements for 3 months. A comparison will be made between the immunological recovery among those patients taking the zinc supplement and those who are not. The CD4 lymphocytes value will be taken as an independent variable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo supplementation | Experimental | Intervention Group B: Patients who will orally receive a placebo for 3 months. |
|
| zinc supplementation | Experimental | Intervention group A. Patients who will orally receive zinc for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc supplementation | Dietary Supplement | Intervention group A: Patients who will orally receive zinc for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunological Recovery | Zinc supplementation is expected to enhance the immunological response of HIV+ patients. This can be demonstrated comparing the initial analysis with the final report (3 months later). | Three months |
| EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS | Compare the variation in levels of CD4 lymphocytes at baseline and three months after surgery (zinc or placebo) in each study patient. | THREE MONTHS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MARCELA DUQUE | Contact | 3136461538 | marduque@gmail.com | |
| HEIDY CONTRERAS | Contact | 3113710971 | heidycm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Heidy Contreras, PhC. | Researcher | Principal Investigator |
| Marcela Duque, MD. | Researcher | Principal Investigator |
| Elsa Vásquez, Biologist |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación SIAM | Recruiting | MedellÃn | Antioquia | Colombia |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069078 | Seroconversion |
| ID | Term |
|---|---|
| D055633 | Immune System Phenomena |
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| Placebo supplementation | Dietary Supplement | Intervention Group B: Patients who will orally receive a placebo for 3 months. |
|
| Researcher |
| Principal Investigator |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |