End Stage Renal DiseasePhase 2NCT02335593

Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients

A Phase 2 study testing Zinc Sulphate, Corn Starch filled Hard Gel Capsules and Epoetin alfa 2000-4000 IU solution for injection in people with End Stage Renal Disease, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: End Stage Renal Disease
What is being tested?: Zinc Sulphate, Corn Starch filled Hard Gel Capsules and Epoetin alfa 2000-4000 IU solution for injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteEgypt
Study dates: Dec 2014to Nov 2015
Phase: Phase 2
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

National Institute of Urology and Nephrology
Cairo, El Matareya

Other trials in Egypt

About this study

Official title: Evaluation of the Effect of Zinc Supplementation on the Health Status of Hemodialysis Patients

Conditions: End Stage Renal Disease
Being tested: Zinc Sulphate, Corn Starch filled Hard Gel Capsules, Epoetin alfa 2000-4000 IU solution for injection, Iron Hydroxide Saccharate Complex Solution for injection
Keywords: Hemodialysis patients, Zinc, Anemia, Oxidative stress
Medical subject headings: Kidney Failure, Chronic, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zinc SulphateDietary supplement
Zinc Sulphate Hard Gel capsules 110mg
Corn Starch filled Hard Gel CapsulesOther
Corn Starch filled Hard Gel Capsules
Epoetin alfa 2000-4000 IU solution for injectionDrug
Epoetin alfa 2000-4000 IU solution for injection
Iron Hydroxide Saccharate Complex Solution for injectionDrug
Iron Hydroxide Saccharate Complex Solution for injection

Study groups in NCT02335593
Study group	Role	What they receive
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. Receives: Dietary Supplement: Zinc Sulphate; Drug: Epoetin alfa 2000-4000 IU solution for injection; Drug: 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. Receives: Other: Corn Starch filled Hard Gel Capsules; Drug: Epoetin alfa 2000-4000 IU solution for injection; Drug: Iron Hydroxide Saccharate Complex Solution for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)
at baseline and after 3 monthes.
Measured: three months

Secondary outcomes (3)

Effect on Oxidative stress (Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase)
Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase at baseline and after 3 monthes.
Measured: three months
Effect on Inflammatory status. (Measurement of C-Reactive protein and Interleukin-6)
Measurement of C-Reactive protein and Interleukin-6 at baseline and after 3 monthes.
Measured: three months
Effect on Fatigue (Fatigue Sevrity Scale)
Using Fatigue Sevrity Scale at baseline and after 3 monthes.
Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Nov 2015

First posted12 Jan 2015 (estimated)
Study startDec 2014
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02335593
Sponsor's protocol ID: PHCL394
Status last verified: Jan 2020
First submitted: 31 Dec 2014
Last updated: 22 Jan 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
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Hypothermic Kidney Machine Perfusion With Omnisol
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Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Zinc Supplementation on the Health Status of Hemodialysis Patients
ClinicalTrials.gov ID: NCT02335593
Acronym / sponsor ID: PHCL394
Conditions: End Stage Renal Disease
Keywords: Hemodialysis patients, Zinc, Anemia, Oxidative stress
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Collaborators: National Institute of Urology and Nephrology
Study start: Dec 2014
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 12 Jan 2015 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Zinc group	Experimental	Dietary Supplement: Zinc Sulphate, Drug: Epoetin alfa 2000-4000 IU solution for injection, Drug: Iron Hydroxide Saccharate Complex Solution for injectionZinc 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.
Placebo group	Active comparator	Other: Corn Starch filled Hard Gel Capsules, Drug: Epoetin alfa 2000-4000 IU solution for injection, Drug: Iron Hydroxide Saccharate Complex Solution for injectionCorn starch filled Hard Gel capsules once daily plus 'Epoetin alfa 2000-4000 IU solution for injection and Iron Hydroxide Saccharate Complex Solution for injection.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

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 SulphateZinc Sulphate Hard Gel capsules 110mg	Dietary supplement	Zinc group
Corn Starch filled Hard Gel CapsulesCorn Starch filled Hard Gel Capsules	Other	Placebo group
Epoetin alfa 2000-4000 IU solution for injectionEpoetin alfa 2000-4000 IU solution for injection	Drug	Placebo group, Zinc group
Iron Hydroxide Saccharate Complex Solution for injectionIron Hydroxide Saccharate Complex Solution for injection	Drug	Placebo group, Zinc group

Primary outcome

Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)
Time frame: three months
at baseline and after 3 monthes.

3 secondary outcomes

Effect on Oxidative stress (Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase)
Time frame: three months
Effect on Inflammatory status. (Measurement of C-Reactive protein and Interleukin-6)
Time frame: three months
Effect on Fatigue (Fatigue Sevrity Scale)
Time frame: three months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

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.

Rasha R. El-kady, Bachelor principal investigator

Ain Shams University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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: finished, as of the sponsor's last update on 22 Jan 2020. 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 Egypt. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin) (time frame: three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02335593.

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 22 Jan 2020.