An interventional study of Zinc gluconate and/or Selenium yeast in HIV, ART and Zinc Deficiency, sponsored by Instituto Nacional de Enfermedades Respiratorias. Status unknown at 1 site in Mexico. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by Instituto Nacional de Enfermedades Respiratorias · Not applicable, Interventional, and Supportive care
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.
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's planned enrollment of 37 is below the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →Instituto Nacional de Enfermedades Respiratorias is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months
Dietary Supplement: Zinc gluconate and/or Selenium yeast
Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months
Dietary Supplement: Zinc gluconate and/or Selenium yeast
Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months
Dietary Supplement: Zinc gluconate and/or Selenium yeast
Participants in this arm will not take supplementation as a control.
30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
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.
Time frame: Baseline and 24 weeks
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
Measure by TBARS
Time frame: Baseline and 24 weeks
Changes in proinflammatory cytokine profile
Measure by LUMINEX
Time frame: Baseline and 24 weeks
Changes in bone metabolism biomarkers
Changes in osteoprotegerin and RANKL levels
Time frame: Baseline and 24 weeks
Frequency of CD4+ T cells
Measure by flow cytometry
Time frame: Baseline,12 and 24 weeks
Changes in total cholesterol
in mg/dL
Time frame: Baseline,12 and 24 weeks
Changes in LDL cholesterol
in mg/dL
Time frame: Baseline,12 and 24 weeks
Changes in HDL cholesterol
in mg/dL
Time frame: Baseline,12 and 24 weeks
Changes in triglycerides
in mg/dL
Time frame: Baseline,12 and 24 weeks
Changes in body weight
in Kg
Time frame: Baseline,12 and 24 weeks
Changes in fat mass
in Kg
Time frame: Baseline,12 and 24 weeks
Changes in lean soft tissue
in Kg
Time frame: Baseline,12 and 24 weeks
Changes in and bone mineral density
g/cm3
Time frame: Baseline,12 and 24 weeks
Started Sep 2016 (actual). Primary completion is estimated for Dec 2019, 39 months after the start.
Of 877 non-industry interventional studies with no phase under Inflammation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 39 months is above that.
Counting every sponsor, half of 924 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Enfermedades Respiratorias