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NCT Number: NCT06847139

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

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chittagong Medical College

Chittagong, Bangladesh

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Acute illness at the time of inclusion.
  • 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.

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Treatment and study plan

Zinc Sulfate 50 Mg Tab

Drug

experimental group will get zinc sulfate

Folic Acid 5 Mg Oral Tablet

Drug

control group will get folic acid

Primary outcomes

  1. change from baseline plasma homocysteine level after intervention

    Time frame: six week

Study contacts

Contact information is provided by the study sponsor or research team.

MD ZAKWAN ULLAH

CONTACT

[email protected]

+8801680560222

Sponsors and collaborators

Lead sponsor

Chittagong Medical College

Other

Registry information

Official study title

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

Acronym: CKD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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