Actively Recruiting

Phase Not Applicable
All Genders
ID06847139

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

Led by Chittagong Medical College · Updated on 2025-05-23

90

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of zinc supplementation compared to folic acid on hyperhomocysteinemia in patients with chronic kidney disease (CKD) who require hemodialysis. Hyperhomocysteinemia, a known risk factor for accelerated cardiovascular problems, is common in CKD patients. Zinc plays an important role in enzymes that metabolize homocysteine, and this study explores its potential to reduce homocysteine levels alongside conventional CKD treatments. The study is an open-label, randomized controlled trial involving 90 CKD patients on maintenance hemodialysis. Participants will be randomly assigned to receive either zinc sulfate (50 mg elemental zinc daily) or folic acid (5 mg daily) for six weeks, along with their usual CKD medications. The trial will be conducted over one and a half years at a medical center in Bangladesh. Participants will have their plasma homocysteine levels measured before and after the six-week treatment period to assess changes. Additional laboratory tests will include serum creatinine, estimated glomerular filtration rate (eGFR), serum albumin, and C-reactive protein (CRP) levels. Safety and any adverse events will be monitored throughout the study. The main goal is to understand how zinc supplementation compares to folic acid in managing hyperhomocysteinemia for CKD patients on hemodialysis.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patient with chronic kidney disease on hemodialysis for at least 3 months
  • Plasma homocysteine level greater than 15 µmol/L
Not Eligible

You will not qualify if you...

  • 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
  • Use of vitamin B 12 supplementation within 6 days, corticosteroids within 18-36 hours, anti-folate or cytotoxic drugs, quinolones, tetracyclines, bisphosphonates
  • Known hypersensitivity to zinc or folic acid

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants receive daily zinc sulfate or folic acid tablets as part of the study intervention.

Weekly visits for up to 6 weeks

Trial Site Locations

Total: 1 location

1

Chittagong Medical College

Chittagong, Bangladesh

Actively Recruiting

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Research Team

M

MD ZAKWAN ULLAH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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