NCT02335593

Brief Summary

The purpose of the study is to evaluate the effect of Zinc supplementation on health status of hemodialysis patients through measurement of the following before and after Zinc administration: Inflammatory markers, Oxidative stress markers and Anemia markers. Also, Evaluation of quality of life of hemodialysis patients before and after Zinc administration using Fatigue severity scale questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

December 31, 2014

Last Update Submit

January 18, 2020

Conditions

End Stage Renal Disease

Keywords

Hemodialysis patientsZincAnemiaOxidative stress

Outcome Measures

Primary Outcomes (1)

  • Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)

    at baseline and after 3 monthes.

    three months

Secondary Outcomes (3)

  • Effect on Oxidative stress (Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase)

    three months

  • Effect on Inflammatory status. (Measurement of C-Reactive protein and Interleukin-6)

    three months

  • Effect on Fatigue (Fatigue Sevrity Scale)

    three months

Study Arms (2)

Zinc group

EXPERIMENTAL

Zinc Sulphate Hard Gel Capsules 110 mg once daily for three months plus Epoetin alfa 2000-4000 IU solution for injection andIron Hydroxide Saccharate Complex Solution for injection.

Dietary Supplement: Zinc SulphateDrug: Epoetin alfa 2000-4000 IU solution for injectionDrug: Iron Hydroxide Saccharate Complex Solution for injection

Placebo group

ACTIVE COMPARATOR

Corn starch filled Hard Gel capsules once daily plus 'Epoetin alfa 2000-4000 IU solution for injection and Iron Hydroxide Saccharate Complex Solution for injection.

Other: Corn Starch filled Hard Gel CapsulesDrug: Epoetin alfa 2000-4000 IU solution for injectionDrug: Iron Hydroxide Saccharate Complex Solution for injection

Interventions

Zinc SulphateDIETARY_SUPPLEMENT

Zinc Sulphate Hard Gel capsules 110mg

Zinc group
Corn Starch filled Hard Gel CapsulesOTHER

Corn Starch filled Hard Gel Capsules

Placebo group
Epoetin alfa 2000-4000 IU solution for injectionDRUG

Epoetin alfa 2000-4000 IU solution for injection

Placebo groupZinc group
Iron Hydroxide Saccharate Complex Solution for injectionDRUG

Iron Hydroxide Saccharate Complex Solution for injection

Placebo groupZinc group

Eligibility Criteria

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

You may qualify if:

  • Under regular hemodialysis for at least 6 months.
  • Clinically stable condition as outpatients.
  • Zinc-deficient patients (plasma Zinc concentrations less than 80 mcg/dl).

You may not qualify if:

  • Patients taking any antioxidant supplements including vitamin E, Omega-3 fatty acids, green tea preparations or immunosuppressive medications within 2 months prior to enrollment in the study.
  • Patients receiving Al hydroxide phosphate binders.
  • Hospitalization in the previous month before the onset of the trial, or having active infection.
  • Patients with malabsorption diseases (e.g, Crohn's disease), liver diseases, cancers, mental retardation, dementia or psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Urology and Nephrology

Cairo, El Matareya, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, ChronicAnemia

Interventions

Zinc SulfateEpoetin AlfaSolutionsInjections

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc CompoundsErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPharmaceutical PreparationsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Rasha R. El-kady, Bachelor

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

December 31, 2014

First Posted

January 12, 2015

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

EG(1)