HIVNCT02162797
Zinc Supplementation Effect on Immune Recovery in HIV Patients
A study testing Zinc supplementation in people with HIV and AIDS, run by CES University at 1 site in Colombia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, AIDS, Immunological Deficiency
- What is being tested?
- Zinc supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- Oct 2013to Jun 2014
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults suffering from HIV/AIDS, over 18 years of age with first- and second-line antiretroviral therapy.
- Patients with two viral loads less than 40 copies/ml (viral supression) and a stable or inferior CD4 lymphocyte count.
- Patients with body mass index over 18.5 kg/m2.
- Patients without opportunistic diseases.
Who cannot join
- Pregnant women.
- Hospitalized patients with cognitive disability evaluated by a doctor.
- Patients who are unwilling to participate.
- Patients taking zinc supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS WITH AN IPS MEDELLIN
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
Read the detailed description
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 Medellín 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 Medellín. 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.
- Being tested
- Zinc supplementation, Placebo supplementation
- Keywords
- HIV, AIDS, zinc, zinc supplement, immunological deficiency
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc supplementationDietary supplement
Also called Zinc Supplementation in Patients With HIV
Intervention group A: Patients who will orally receive zinc for 3 months.
Placebo supplementationDietary supplement
Intervention Group B: Patients who will orally receive a placebo for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo supplementation | Experimental | Intervention Group B: Patients who will orally receive a placebo for 3 months. Receives: Dietary Supplement: Placebo supplementation |
| zinc supplementation | Experimental | Intervention group A. Patients who will orally receive zinc for 3 months. Receives: Dietary Supplement: Zinc supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: THREE MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Collaborators
- IPS Fundación SIAM
- Responsible party
- Principal investigator, Heidy Contreras, CES University
- Investigators
- Heidy Contreras, PhC., Principal investigator, ResearcherMarcela Duque, MD., Principal investigator, ResearcherElsa Vásquez, Biologist, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162797
- Sponsor's protocol ID
- SUPL002
- Status last verified
- Jun 2014
- First submitted
- 29 May 2014
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS WITH AN IPS MEDELLIN
- ClinicalTrials.gov ID
- NCT02162797
- Acronym / sponsor ID
- SUPL002
- Keywords
- HIV, AIDS, zinc, zinc supplement, immunological deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Collaborators
- IPS Fundación SIAM
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 13 Jun 2014 (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.
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
Detailed description
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 Medellín 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 Medellín. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo supplementation | Experimental | Dietary Supplement: Placebo supplementationIntervention Group B: Patients who will orally receive a placebo for 3 months. |
| zinc supplementation | Experimental | Dietary Supplement: Zinc supplementationIntervention group A. Patients who will orally receive zinc for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults suffering from HIV/AIDS, over 18 years of age with first- and second-line antiretroviral therapy.
- Patients with two viral loads less than 40 copies/ml (viral supression) and a stable or inferior CD4 lymphocyte count.
- Patients with body mass index over 18.5 kg/m2.
- Patients without opportunistic diseases.
Key exclusion criteria (4 listed)
- Pregnant women.
- Hospitalized patients with cognitive disability evaluated by a doctor.
- Patients who are unwilling to participate.
- Patients taking zinc supplements.
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 |
|---|---|---|
| Zinc supplementationAlso: Zinc Supplementation in Patients With HIVIntervention group A: Patients who will orally receive zinc for 3 months. | Dietary supplement | zinc supplementation |
| Placebo supplementationIntervention Group B: Patients who will orally receive a placebo for 3 months. | Dietary supplement | Placebo supplementation |
Primary outcome
Immunological Recovery
Time frame: Three months
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).
EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS
Time frame: THREE MONTHS
Compare the variation in levels of CD4 lymphocytes at baseline and three months after surgery (zinc or placebo) in each study patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
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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.
Heidy Contreras, PhC. principal investigator
Researcher
Marcela Duque, MD. principal investigator
Researcher
Elsa Vásquez, Biologist principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc supplementation in people with HIV and AIDS, run by CES University at 1 site in Colombia.
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: status not confirmed, as of the sponsor's last update on 13 Jun 2014. 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 Colombia. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARCELA DUQUE (3136461538, marduque@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological Recovery (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2014.