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Completed

NCT Number: NCT07825961

Efficacy of Melatonin in the Treatment of Diabetic Nephropathy Compared With Folic Acid

The current study aims to investigate and compare the anti-inflammatory effects of melatonin versus folic acid in patients with diabetic nephropathy.

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Key information

Conditions

Melatonin Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Folic Acid Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Diabetes mellitus (DM) is a metabolic disorder characterized by chronic hyperglycemia, resulting from either insufficient insulin production (Type I) or ineffective insulin utilization (Type II).

Melatonin, a hormone produced by the pineal gland, regulates circadian rhythms and exhibits strong antioxidant, anti-inflammatory, and immunomodulatory properties.

Folic acid, a B-vitamin essential for cell division and DNA synthesis, also exerts antioxidant effects and supports endothelial function by lowering plasma homocysteine levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18-75 years.
  • Patients with a confirmed diagnosis of Type 2 diabetes and diabetic nephropathy, as indicated by an elevated urine albumin-to-creatinine ratio (UACR ≥ 30 mg/g) or a decreased estimated glomerular filtration rate (eGFR < 60 mL/min/1.73 m²).

Exclusion criteria

  • Patients who are expectant or breastfeeding.
  • Have significant comorbidities.
  • Have rapidly declining renal function.
  • Have acute kidney injury.

Treatment and study plan

Conventional diabetic treatment

Drug

Patients in the control group will receive conventional diabetic treatment.

Folic Acid

Drug

Patients who received receive normal therapy augmented with folic acid (400 µg/day).

Melatonin

Drug

Patients who receive standard therapy supplemented with melatonin (3 mg/day).

Primary outcomes

  1. Change in the urine albumin-to-creatinine ratio (UACR)

    Time frame: 12-week after treatment

    Change in the urine albumin-to-creatinine ratio (UACR) will be recorded. The UACR is an important biomarker of kidney impairment because it measures the quantity of albumin discharged in the urine in relation to creatinine levels. Elevated UACR readings (≥ 30 mg/g) indicate albuminuria, a symptom of diabetic nephropathy.

Secondary outcomes

  1. Change in the estimated glomerular filtration rate (eGFR)

    Time frame: 12-week after treatment

    Change in the estimated glomerular filtration rate (eGFR) will be recorded. eGFR, which estimates the kidneys' filtering ability based on serum creatinine levels, age, sex, and race. A low eGFR (less than 60 mL/min/1.73 m²) may suggest chronic renal damage caused by diabetes.

  2. Change in the serum creatinine

    Time frame: 12-week after treatment

    Change in the serum creatinine level will be recorded. Serum creatinine is a waste product produced by muscle metabolism, and excessive levels suggest poor kidney function, since the kidneys may struggle to filter waste properly.

  3. Change in the neutrophil gelatinase-associated lipocalin (NGAL)

    Time frame: 12-week after treatment

    Change in the neutrophil gelatinase-associated lipocalin (NGAL) will be recorded. Neutrophil gelatinase-associated lipocalin is a protein produced by the kidneys in response to injury or damage, and increased levels are related with both acute kidney injury (AKI) and chronic kidney disease (CKD).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

A Comparative Clinical Study to Evaluate the Efficacy of Melatonin in the Treatment of Diabetic Nephropathy Compared With Folic Acid

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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