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

NCT07825961 | Completed

• 1 other identifier: MDP.25.04.182
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melatonin; Diabetic Nephropathy; Folic Acid

Outcome Measures

Primary Outcomes (1)

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

  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.

  12-week after treatment

Secondary Outcomes (3)

• Change in the estimated glomerular filtration rate (eGFR)

  12-week after treatment

• Change in the serum creatinine

  12-week after treatment

• Change in the neutrophil gelatinase-associated lipocalin (NGAL)

  12-week after treatment

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Patients in the control group will receive conventional diabetic treatment.

Drug: Conventional diabetic treatment

Group 2

EXPERIMENTAL

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

Drug: Folic acid

Group 3

EXPERIMENTAL

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

Drug: Melatonin

Interventions

Conventional diabetic treatment DRUG

Patients in the control group will receive conventional diabetic treatment.

Group 1

Folic acid DRUG

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

Group 2

Melatonin DRUG

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

Group 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Folic Acid; Melatonin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tryptamines; Indoles; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc in Pharmacy (Clinical Pharmacy), Faculty of Pharmacy, Tanta University, Egypt

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: April 1, 2025
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)