RecruitingNot ApplicableNCT06847139

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

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


Sponsor

Chittagong Medical College

Enrollment

90 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is comparing zinc supplements to folic acid supplements in lowering high homocysteine levels (a chemical in the blood linked to heart and kidney disease complications) in people with chronic kidney disease who are on dialysis. **You may be eligible if...** - You are 18 years of age or older - You have chronic kidney disease and have been on hemodialysis (a blood-filtering treatment) for at least 3 months - Your blood homocysteine level is above 15 µmol/L (your doctor can check this) **You may NOT be eligible if...** - You are currently acutely ill - You have a condition affecting nutrient absorption (malabsorption) - You are planning major surgery soon - You have received or are planned to receive a kidney transplant - You have taken zinc or folic acid supplements in the past month - You take certain medications that interact with these supplements (e.g., certain antibiotics, steroids, or chemotherapy drugs) - You are allergic to zinc or folic acid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZinc Sulfate 50 Mg Tab

experimental group will get zinc sulfate

DRUGFolic Acid 5 Mg Oral Tablet

control group will get folic acid


Locations(1)

Chittagong Medical College

Chittagong, Bangladesh

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NCT06847139


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