Zinc vs. Folic Acid for Lowering Homocysteine in Kidney Patients on Dialysis
Effect of Zinc Supplementation on Hyperhomocysteinemia Compared to That of Folic Acid in Patients of Chronic Kidney Disease on Hemodialysis-A Randomized Controlled Trial.
This study is testing whether zinc supplements can lower high homocysteine levels better than folic acid in kidney patients on dialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | Chittagong Medical College Academic / other |
| Locations | 1 site (Chittagong) |
| Trial ID | NCT06847139 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of zinc supplementation compared to folic acid in reducing hyperhomocysteinemia in patients with chronic kidney disease undergoing hemodialysis. Hyperhomocysteinemia is a significant risk factor for cardiovascular events in these patients. The study will randomly assign ninety participants to receive either zinc sulfate or folic acid over a period of one and a half years at Chittagong Medical College Hospital in Bangladesh. The aim is to determine if zinc can provide a more effective solution for managing elevated homocysteine levels in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic kidney disease on hemodialysis for at least three months and elevated plasma homocysteine levels.
Not a fit: Patients with acute illnesses, malabsorption issues, or those receiving certain medications or supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option to reduce cardiovascular risks in hemodialysis patients.
How similar studies have performed: While folic acid has been widely studied and shown efficacy, the use of zinc supplementation in this context is less established, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. \-
Where this trial is running
Chittagong
- Chittagong Medical College — Chittagong, Bangladesh (Recruiting)
Study contacts
- Study coordinator: Md Zakwan Ullah
- Email: zakwan.cmc@gmail.com
- Phone: +8801680560222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.