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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChittagong Medical College

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Acute illness at the time of inclusion.

Diagnosed case of malabsorption

Planned major surgery

Renal transplantation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: patient getting zinc sulfateExperimental treatment 1 intervention
Group B: patient getting folic acidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

change from baseline plasma homocysteine level after intervention

Time frame
six week

Secondary outcomes

Other outcomes

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