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

NCT06847139 | Recruiting DMC

• 1 other identifier: PG.2024/1072
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease Requiring Hemodialysis

Outcome Measures

Primary Outcomes (1)

• change from baseline plasma homocysteine level after intervention

  six week

Study Arms (2)

patient getting zinc sulfate

EXPERIMENTAL

patient will get zinc sulfate 50 mg daily

Drug: Zinc Sulfate 50 Mg Tab

patient getting folic acid

ACTIVE COMPARATOR

patient will get folic acid 5 mg

Drug: Folic Acid 5 Mg Oral Tablet

Interventions

Zinc Sulfate 50 Mg Tab DRUG

experimental group will get zinc sulfate

patient getting zinc sulfate

Folic Acid 5 Mg Oral Tablet DRUG

control group will get folic acid

patient getting folic acid

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diagnosed case of malabsorption
• Planned major surgery
• Renal transplantation
• Receiving zinc or folic acid supplementation within the previous month from enrollment.
• Concomitant use of vitamin B 12 supplementation(6 days), corticosteroid (18-36 hour), anti folate or cytotoxic drugs, quinolones, tetracyclines, bisphosphonates.
• Known hypersensitivity to zinc or folic acid.

Sponsors & Collaborators

• Chittagong Medical College: lead

Study Sites (1)

Chittagong Medical College

Chittagong, Bangladesh

RECRUITING

MeSH Terms

Interventions

Zinc Sulfate; Folic Acid; Tablets

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

MD ZAKWAN ULLAH

CONTACT

+8801680560222; zakwan.cmc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: July 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: October 30, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

BA (1)