MelatoninNCT07825961
Efficacy of Melatonin in the Treatment of Diabetic Nephropathy Compared With Folic Acid
A study testing Conventional diabetic treatment, Folic acid and Melatonin in people with Melatonin and Diabetic Nephropathy, run by Tanta University at 1 site in Egypt.
Trial summary
The current study aims to investigate and compare the anti-inflammatory effects of melatonin versus folic acid in patients with diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melatonin, Diabetic Nephropathy, Folic Acid
- What is being tested?
- Conventional diabetic treatment, Folic acid and Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients who are expectant or breastfeeding.
- Have significant comorbidities.
- Have rapidly declining renal function.
- Have acute kidney injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Clinical Study to Evaluate the 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.
Read the detailed description
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.
- Conditions
- Melatonin, Diabetic Nephropathy, Folic Acid
- Being tested
- Conventional diabetic treatment, Folic acid, Melatonin
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional diabetic treatmentDrug
Patients in the control group will receive conventional diabetic treatment.
Folic acidDrug
Patients who received receive normal therapy augmented with folic acid (400 µg/day).
MelatoninDrug
Patients who receive standard therapy supplemented with melatonin (3 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients in the control group will receive conventional diabetic treatment. Receives: Drug: Conventional diabetic treatment |
| Group 2 | Experimental | Patients who received receive normal therapy augmented with folic acid (400 µg/day). Receives: Drug: Folic acid |
| Group 3 | Experimental | Patients who receive standard therapy supplemented with melatonin (3 mg/day). Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-week after treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: 12-week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Apr 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelatoninStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ghodaer Alshamri, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825961
- Sponsor's protocol ID
- MDP.25.04.182
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Study to Evaluate the Efficacy of Melatonin in the Treatment of Diabetic Nephropathy Compared With Folic Acid
- ClinicalTrials.gov ID
- NCT07825961
- Acronym / sponsor ID
- MDP.25.04.182
- Conditions
- Melatonin, Diabetic Nephropathy, Folic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to investigate and compare the anti-inflammatory effects of melatonin versus folic acid in patients with diabetic nephropathy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Conventional diabetic treatmentPatients in the control group will receive conventional diabetic treatment. |
| Group 2 | Experimental | Drug: Folic acidPatients who received receive normal therapy augmented with folic acid (400 µg/day). |
| Group 3 | Experimental | Drug: MelatoninPatients who receive standard therapy supplemented with melatonin (3 mg/day). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- Patients who are expectant or breastfeeding.
- Have significant comorbidities.
- Have rapidly declining renal function.
- Have acute kidney injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional diabetic treatmentPatients in the control group will receive conventional diabetic treatment. | Drug | Group 1 |
| Folic acidPatients who received receive normal therapy augmented with folic acid (400 µg/day). | Drug | Group 2 |
| MelatoninPatients who receive standard therapy supplemented with melatonin (3 mg/day). | Drug | Group 3 |
Primary outcome
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.
3 secondary outcomes
Change in the estimated glomerular filtration rate (eGFR)
Time frame: 12-week after treatment
Change in the serum creatinine
Time frame: 12-week after treatment
Change in the neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: 12-week after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional diabetic treatment, Folic acid and Melatonin in people with Melatonin and Diabetic Nephropathy, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the urine albumin-to-creatinine ratio (UACR) (time frame: 12-week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.