An interventional study of Conventional diabetic treatment and Folic acid in Melatonin, Diabetic Nephropathy and Folic Acid, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
The current study aims to investigate and compare the anti-inflammatory effects of melatonin versus folic acid in patients with diabetic nephropathy.
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.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
This study's enrollment of 75 is close to the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the control group will receive conventional diabetic treatment.
Drug: Conventional diabetic treatment
Patients who received receive normal therapy augmented with folic acid (400 µg/day).
Drug: Folic acid
Patients who receive standard therapy supplemented with melatonin (3 mg/day).
Drug: Melatonin
Patients in the control group will receive conventional diabetic treatment.
Patients who received receive normal therapy augmented with folic acid (400 µg/day).
Patients who receive standard therapy supplemented with melatonin (3 mg/day).
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.
Time frame: 12-week after treatment
Change in the estimated glomerular filtration rate (eGFR)
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.
Time frame: 12-week after treatment
Change in the serum creatinine
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.
Time frame: 12-week after treatment
Change in the neutrophil gelatinase-associated lipocalin (NGAL)
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).
Time frame: 12-week after treatment
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: 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.
No publications or documents are linked to this record.
Ran from Apr 2025 to primary completion in Jul 2026, 15 months.
Of 49 non-industry interventional studies with no phase under Diabetic Nephropathies, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's 15 months is below that.
Counting every sponsor, half of 50 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Folic Acid · Melatonin