Effect of Zinc Supplementation on Hyperhomocysteinemia Compared to Folic Acid in CKD Patient on Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-10-30

Brief Summary

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Hyperhomocysteinemia is a well-recognized risk factor for accelerated cardiovascular events in hemodialysis patients. Hyperhomocysteinemia is common in individuals with chronic kidney disease (CKD). Zinc is a vital cofactor for homocysteine metabolism enzymes. Although numerous studies have demonstrated the efficacy of folic acid in hyperhomocysteinemia, zinc supplementation has the potential to reduce homocysteine levels in hemodialysis patients. Objective: To evaluate the effect of Zinc supplementation on hyperhomocysteinemia compared to that of folic acid in patients with chronic kidney disease on hemodialysis. Materials and Methods: This open-label randomized active-controlled trial will be conducted in the Department of Nephrology of Chittagong Medical College Hospital, Chattogram, Bangladesh, for one and a half years. A total of ninety CKD patients on maintenance hemodialysis will be included in the study. Patients will be randomly divided into two groups. The experimental group will be treated with zinc sulfate (50 mg elemental zinc/day) for six weeks in conjunction with conventional treatment for CKD. The Control group will receive folic acid (5mg/day) along with conventional medications for CKD. The primary outcome measure will be the change in the plasma homocysteine level after 6 weeks, while the other variables will include serum creatinine, eGFR, serum albumin and C-reactive protein (CRP) level. Adverse events and safety measures will also be recorded. The primary analysis will be an intention to treat analysis performed with SPSS-23. Data from previous studies indicate zinc supplementation can reduce homocysteine levels in CKD patients facilitating its metabolism. Additionally, the anti-inflammatory properties of zinc may facilitate homocysteine reduction. Moreover, zinc is crucial in various physiological processes, including immune function, protein synthesis, and wound healing. Further clinical trials are still needed to understand better the safety and efficacy of zinc supplementation in CKD patients.

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Detailed Description

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Conditions

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Chronic Kidney Disease Requiring Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patient getting zinc sulfate

patient will get zinc sulfate 50 mg daily

Group Type EXPERIMENTAL

Zinc Sulfate 50 Mg Tab

Intervention Type DRUG

experimental group will get zinc sulfate

patient getting folic acid

patient will get folic acid 5 mg

Group Type ACTIVE_COMPARATOR

Folic Acid 5 Mg Oral Tablet

Intervention Type DRUG

control group will get folic acid

Interventions

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Zinc Sulfate 50 Mg Tab

experimental group will get zinc sulfate

Intervention Type DRUG

Folic Acid 5 Mg Oral Tablet

control group will get folic acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Age ≥18 years 2. Patient with chronic kidney disease on HD for ≥ 3 months 3. Plasma homocysteine level \> 15μmol/L

Exclusion Criteria

1. Acute illness at the time of inclusion.
2. Diagnosed case of malabsorption
3. Planned major surgery
4. Renal transplantation
5. Receiving zinc or folic acid supplementation within the previous month from enrollment.
6. Concomitant use of vitamin B 12 supplementation(6 days), corticosteroid (18-36 hour), anti folate or cytotoxic drugs, quinolones, tetracyclines, bisphosphonates.
7. Known hypersensitivity to zinc or folic acid.

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Eligible Sex

ALL

Accepts Healthy Volunteers

No