Effect of Zinc Supplementation on Hyperhomocysteinemia Compared to Folic Acid in CKD Patient on Hemodialysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zinc Sulfate 50 Mg Tab, Folic Acid 5 Mg Oral Tablet.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease Requiring Hemodialysis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Interventions
- Drug Zinc Sulfate 50 Mg Tab
experimental group will get zinc sulfate - Drug Folic Acid 5 Mg Oral Tablet
control group will get folic acid
Primary outcome measures
- change from baseline plasma homocysteine level after intervention [Time frame: six week]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bangladesh · 1 center
- Chittagong Medical College — Chittagong
Identifiers
NCT: NCT06847139 · PG.2024/1072