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

Effect of Zinc Supplementation on Hyperhomocysteinemia Compared to That of Folic Acid in Patients of Chronic Kidney Disease on Hemodialysis-A Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease Requiring Hemodialysis
• Intervention / Treatment: Drug: Zinc Sulfate 50 Mg Tab; Drug: Folic Acid 5 Mg Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MD ZAKWAN ULLAH; Phone Number: +8801680560222; Email: zakwan.cmc@gmail.com

Study Locations

• Bangladesh
  • Chittagong, Bangladesh
    • Recruiting
    • Chittagong Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient getting zinc sulfate; patient will get zinc sulfate 50 mg daily	Drug: Zinc Sulfate 50 Mg Tab; experimental group will get zinc sulfate
Active Comparator: patient getting folic acid; patient will get folic acid 5 mg	Drug: Folic Acid 5 Mg Oral Tablet; control group will get folic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline plasma homocysteine level after intervention	six week

Collaborators and Investigators

• Sponsor: Chittagong Medical College

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Renal Insufficiency; Malabsorption Syndromes; Amino Acid Metabolism, Inborn Errors; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Kidney Diseases; Renal Insufficiency, Chronic; Hyperhomocysteinemia; Physiological Effects of Drugs; Dermatologic Agents; Micronutrients; Vitamin B Complex; Vitamins; Hematinics; Astringents; Folic Acid; Zinc Sulfate
• Other Study ID Numbers: PG.2024/1072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No