NCT02162797

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
Last Updated

June 13, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

May 29, 2014

Last Update Submit

June 12, 2014

Conditions

HIVAIDSImmunological DeficiencyInadequate Immune RecoveryViral Replication

Keywords

HIVAIDSzinczinc supplementimmunological deficiency

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Placebo supplementation

EXPERIMENTAL

Intervention Group B: Patients who will orally receive a placebo for 3 months.

Dietary Supplement: Placebo supplementation

zinc supplementation

EXPERIMENTAL

Intervention group A. Patients who will orally receive zinc for 3 months.

Dietary Supplement: Zinc supplementation

Interventions

Zinc supplementationDIETARY_SUPPLEMENT

Intervention group A: Patients who will orally receive zinc for 3 months.

Also known as: Zinc Supplementation in Patients With HIV
zinc supplementation
Placebo supplementationDIETARY_SUPPLEMENT

Intervention Group B: Patients who will orally receive a placebo for 3 months.

Placebo supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant women.
  • Hospitalized patients with cognitive disability evaluated by a doctor.
  • Patients who are unwilling to participate.
  • Patients taking zinc supplements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación SIAM

Medellín, Antioquia, Colombia

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

  • Heidy Contreras, PhC.

    Researcher

    PRINCIPAL INVESTIGATOR

  • Marcela Duque, MD.

    Researcher

    PRINCIPAL INVESTIGATOR

  • Elsa Vásquez, Biologist

    Researcher

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MARCELA DUQUE

CONTACT

3136461538marduque@gmail.com

HEIDY CONTRERAS

CONTACT

3113710971heidycm@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 13, 2014

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 13, 2014

Record last verified: 2014-06

Locations

CO(1)