NCT06847139 Effect of Zinc Supplementation on Hyperhomocysteinemia Compared to Folic Acid in CKD Patient on Hemodialysis
| NCT ID | NCT06847139 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chittagong Medical College |
| Condition | Chronic Kidney Disease Requiring Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-07-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-07-01 with a primary completion date of 2025-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: 1. Acute illness at the time of inclusion. 2. Diagnosed case of malabsorption 3. Planned major surgery 4. Renal transplantation 5. Receiving zinc or folic acid supplementation within the previous month from enrollment. 6. Concomitant use of vitamin B 12 supplementation(6 days), corticosteroid (18-36 hour), anti folate or cytotoxic drugs, quinolones, tetracyclines, bisphosphonates. 7. Known hypersensitivity to zinc or folic acid. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06847139 clinical trial?
This trial is open to participants of all sexes, studying Chronic Kidney Disease Requiring Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06847139 currently recruiting?
Yes, NCT06847139 is actively recruiting participants. Contact the research team at zakwan.cmc@gmail.com for enrollment information.
Where is the NCT06847139 trial being conducted?
This trial is being conducted at Chittagong, Bangladesh.
Who is sponsoring the NCT06847139 clinical trial?
NCT06847139 is sponsored by Chittagong Medical College. The trial plans to enroll 90 participants.
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