HIVNCT03421314
Effect of Zinc and Selenium Supplementation on HIV+ Individuals on Antiretroviral Treatment.
A study testing Zinc gluconate and/or Selenium yeast in people with HIV and ART, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
Trial summary
The aim of this study is to evaluate the effect of zinc gluconate and/or selenium yeast supplementation during six months on clinical (glucose, cholesterol, triglycerides, bone mineral density and body composition) and immunological (oxidative stress, CD4+ count and pro-inflammatory cytokines) parameters in a… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- HIV, ART, Zinc Deficiency
- What is being tested?
- Zinc gluconate and/or Selenium yeast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2016to 1 Jan 2020
- 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- >200 CD4+ cells/mL
- >2 years under antiretroviral treatment
- >2 years under virology control (HIV RNA <40 copies/mL)
Who cannot join
- Patients with opportunistic infection
- Patients taking vitamin-mineral supplements
- Patients with moderate or high cardiovascular risk (Framingham score higher than 10%) and cholesterol LDL >190 mg/dL or triglycerides >500 mg/dL.
- Patients with diabetes or hypertension diagnosis.
- Patients taking drugs for diabetes, hypertension, dyslipidemia or low bone mass density.
- Low adherence to supplementation.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro de Investigaciones en Enfermedades Infecciosas
Mexico City, Mexico City, 14080
Ivan Osuna Padilla, MD, 56667085 ext. 109, ivan.osuna@cieni.org.mx
Gustavo Reyes-Terán, MD
About this study
Official title: Effect of Zinc and Selenium Supplementation on Clinical and Immunological Parameters on HIV+ Individuals on Antiretroviral Treatment.
The aim of this study is to evaluate the effect of zinc gluconate and/or selenium yeast supplementation during six months on clinical (glucose, cholesterol, triglycerides, bone mineral density and body composition) and immunological (oxidative stress, CD4+ count and pro-inflammatory cytokines) parameters in a population with HIV diagnosis on antiretroviral treatment.
Read the detailed description
HIV-infected individuals on antiretroviral treatment have lowest risk of AIDS events and more life expectancy. However, antiretroviral treatment does not fully restore the immune system in all individuals due to persistent immune activation and inflammation, increasing the risk of non-AIDS complications, such as insulin resistance, diabetes, hypertension, dyslipidemia, obesity, low bone mass density, oxidative stress and micronutrient deficiencies. Several studies showed that HIV+ patients present zinc and selenium deficiency. Those micronutrients are involved in the pathogenesis of metabolic complications and have a major role in maintaining immune system function. It remains unknown the effect of zinc and selenium supplementation on metabolic and immunological parameters associated to non-AIDS complications.
- Conditions
- HIV, ART, Zinc Deficiency, Selenium Deficiency, Metabolic Complication, Inflammation
- Being tested
- Zinc gluconate and/or Selenium yeast
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc gluconate and/or Selenium yeastDietary supplement
30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
| Study group | Role | What they receive |
|---|---|---|
| Zinc | Experimental | Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months Receives: Dietary Supplement: Zinc gluconate and/or Selenium yeast |
| Selenium | Experimental | Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months Receives: Dietary Supplement: Zinc gluconate and/or Selenium yeast |
| Zinc + Selenium | Experimental | Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months Receives: Dietary Supplement: Zinc gluconate and/or Selenium yeast |
| Control | No intervention | Participants in this arm will not take supplementation as a control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in zinc and selenium plasmatic levels
We evaluated the effects of zinc (30mg/d) and selenium (200μg/d) supplementation on plasma zinc and selenium levels.
Measured: Baseline and 24 weeks
Secondary outcomes (15)
Counts of CD4+ T cells
Measured: Baseline,12 and 24 weeks
Changes in fasting serum glucose
Measured: Baseline,12 and 24 weeks
Changes in blood pressure
Measured: Baseline,12 and 24 weeks
Changes in lipid peroxidation
Measure by TBARS
Measured: Baseline and 24 weeks
Changes in proinflammatory cytokine profile
Measure by LUMINEX
Measured: Baseline and 24 weeks
Changes in bone metabolism biomarkers
Changes in osteoprotegerin and RANKL levels
Measured: Baseline and 24 weeks
Frequency of CD4+ T cells
Measure by flow cytometry
Measured: Baseline,12 and 24 weeks
Changes in total cholesterol
in mg/dL
Measured: Baseline,12 and 24 weeks
Changes in LDL cholesterol
in mg/dL
Measured: Baseline,12 and 24 weeks
Changes in HDL cholesterol
in mg/dL
Measured: Baseline,12 and 24 weeks
Changes in triglycerides
in mg/dL
Measured: Baseline,12 and 24 weeks
Changes in body weight
in Kg
Measured: Baseline,12 and 24 weeks
Changes in fat mass
in Kg
Measured: Baseline,12 and 24 weeks
Changes in lean soft tissue
in Kg
Measured: Baseline,12 and 24 weeks
Changes in and bone mineral density
g/cm3
Measured: Baseline,12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Sep 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Jan 2020 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gustavo Reyes-Teran, Instituto Nacional de Enfermedades Respiratorias
- Investigators
- Gustavo Reyes Teran, MD, Principal investigator, Principal investgator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421314
- Sponsor's protocol ID
- C21-16
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc and Selenium Supplementation on Clinical and Immunological Parameters on HIV+ Individuals on Antiretroviral Treatment.
- ClinicalTrials.gov ID
- NCT03421314
- Acronym / sponsor ID
- C21-16
- Conditions
- HIV, ART, Zinc Deficiency, Selenium Deficiency, Metabolic Complication, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Instituto Nacional de Enfermedades RespiratoriasOther government
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 5 Feb 2018 (actual)
- 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 aim of this study is to evaluate the effect of zinc gluconate and/or selenium yeast supplementation during six months on clinical (glucose, cholesterol, triglycerides, bone mineral density and body composition) and immunological (oxidative stress, CD4+ count and pro-inflammatory cytokines) parameters in a population with HIV diagnosis on antiretroviral treatment.
Detailed description
HIV-infected individuals on antiretroviral treatment have lowest risk of AIDS events and more life expectancy. However, antiretroviral treatment does not fully restore the immune system in all individuals due to persistent immune activation and inflammation, increasing the risk of non-AIDS complications, such as insulin resistance, diabetes, hypertension, dyslipidemia, obesity, low bone mass density, oxidative stress and micronutrient deficiencies. Several studies showed that HIV+ patients present zinc and selenium deficiency. Those micronutrients are involved in the pathogenesis of metabolic complications and have a major role in maintaining immune system function. It remains unknown the effect of zinc and selenium supplementation on metabolic and immunological parameters associated to non-AIDS complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zinc | Experimental | Dietary Supplement: Zinc gluconate and/or Selenium yeastParticipants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months |
| Selenium | Experimental | Dietary Supplement: Zinc gluconate and/or Selenium yeastParticipants in this arm will take a daily 200 mcg of selenium yeast during 6 months |
| Zinc + Selenium | Experimental | Dietary Supplement: Zinc gluconate and/or Selenium yeastParticipants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months |
| Control | No intervention | –Participants in this arm will not take supplementation as a control. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infected
- >200 CD4+ cells/mL
- >2 years under antiretroviral treatment
- >2 years under virology control (HIV RNA <40 copies/mL)
Key exclusion criteria (6 listed)
- Patients with opportunistic infection
- Patients taking vitamin-mineral supplements
- Patients with moderate or high cardiovascular risk (Framingham score higher than 10%) and cholesterol LDL >190 mg/dL or triglycerides >500 mg/dL.
- Patients with diabetes or hypertension diagnosis.
- Patients taking drugs for diabetes, hypertension, dyslipidemia or low bone mass density.
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 gluconate and/or Selenium yeast30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast | Dietary supplement | Selenium, Zinc, Zinc + Selenium |
Primary outcome
Changes from baseline in zinc and selenium plasmatic levels
Time frame: Baseline and 24 weeks
We evaluated the effects of zinc (30mg/d) and selenium (200μg/d) supplementation on plasma zinc and selenium levels.
15 secondary outcomes
Counts of CD4+ T cells
Time frame: Baseline,12 and 24 weeks
Changes in fasting serum glucose
Time frame: Baseline,12 and 24 weeks
Changes in blood pressure
Time frame: Baseline,12 and 24 weeks
Changes in lipid peroxidation
Time frame: Baseline and 24 weeks
Changes in proinflammatory cytokine profile
Time frame: Baseline and 24 weeks
Changes in bone metabolism biomarkers
Time frame: Baseline and 24 weeks
Frequency of CD4+ T cells
Time frame: Baseline,12 and 24 weeks
Changes in total cholesterol
Time frame: Baseline,12 and 24 weeks
Changes in LDL cholesterol
Time frame: Baseline,12 and 24 weeks
Changes in HDL cholesterol
Time frame: Baseline,12 and 24 weeks
Changes in triglycerides
Time frame: Baseline,12 and 24 weeks
Changes in body weight
Time frame: Baseline,12 and 24 weeks
Changes in fat mass
Time frame: Baseline,12 and 24 weeks
Changes in lean soft tissue
Time frame: Baseline,12 and 24 weeks
Changes in and bone mineral density
Time frame: Baseline,12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
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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.
Gustavo Reyes Teran, MD principal investigator
Principal investgator
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 gluconate and/or Selenium yeast in people with HIV and ART, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
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 6 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 30 Jan 2019. 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 Mexico. 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 Ivan Osuna Padilla, MD (56667985 ext. 109, ivan.osuna@cieni.org.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in zinc and selenium plasmatic levels (time frame: Baseline and 24 weeks). 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 30 Jan 2019.