Peritoneal DialysisNCT06096558
The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients
A study testing Melatonin in people with Peritoneal Dialysis, run by National Nutrition and Food Technology Institute.
Trial summary
The aim of this double-blind randomized clinical trial is to determine the effects of Melatonin on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of advanced glycated end products and quality of life in peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 1 May 2024
- 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
- Continuous Ambulatory Peritoneal Dialysis for 6 months or more
- Body mass index (BMI) below 35
Who cannot join
- Infectious diseases (especially peritonitis) and inflammatory diseases Liver diseases
- Past medical history of cancer Receiving glucocorticoid drugs, non-steroidal anti-inflammatory drugs
- Receiving Melatonin supplements
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Melatonin, as a Dietary Supplement, on Glycemic Parameters, Cardiovascular Disease Risk Factors, Bone Metabolism Markers and Quality of Life in Peritoneal Dialysis Patients
The aim of this double-blind randomized clinical trial is to determine the effects of Melatonin on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of advanced glycated end products and quality of life in peritoneal dialysis patients. Forty patients from peritoneal dialysis centers will randomly assign to either Melatonin or placebo group. The patients in Melatonin group will receive 5 mg Melatonin (as 1 tablet) daily for 10 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and Serum concentrations of malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; glucose; pentosidine; carboxy-methyl lysine; Procollagen 1 Intact N-Terminal Propeptide; Tartrate-resistant acid phosphatase 5b; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; lipoprotein-a; albumin; calcium; phosphorous; and also systolic blood pressure; diastolic blood pressure and questionnaires including quality of life; quality of sleep and depression will be assessed.
- Conditions
- Peritoneal Dialysis
- Being tested
- Melatonin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
5 mg Melatonin in one tablet, 30 minutes before night sleep
placeboOther
1 tablet of placebo (starch)
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | Not described Receives: Dietary Supplement: Melatonin |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lp (a)
Serum concentrations of lipoprotein-a
Measured: 10 weeks
MDA
Serum concentrations of malondialdehyde
Measured: 10 weeks
hs-CRP
Serum concentrations of high sensitivity c-reactive protein
Measured: 10 weeks
sICAM-1
Serum concentrations of Soluble intercellular adhesion molecule-1
Measured: 10 weeks
glucose
serum concentration of fasting glucose
Measured: 10 weeks
pentosidine
serum concentration of pentosidine
Measured: 10 weeks
carboxy-methyl lysine
serum concentration of carboxy-methyl lysine
Measured: 10 weeks
P1NP
serum concentration of Procollagen 1 Intact N-Terminal Propeptide
Measured: 10 weeks
Osteoprotegerin
Serum concentrations of Osteoprotegerin
Measured: 10 weeks
TRACP5b
Serum concentrations of Tartrate-resistant acid phosphatase 5b
Measured: 10 weeks
RANKL
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Measured: 10 weeks
Systolic blood pressure
Systolic blood pressure (mmHg)
Measured: 10 weeks
Diastolic blood pressure
Diastolic blood pressure (mmHg)
Measured: 10 weeks
triglyceride
Serum concentrations of triglyceride
Measured: 10 weeks
Total cholesterol
Serum concentrations of total cholesterol
Measured: 10 weeks
HDL-C
Serum concentrations of High-density lipoprotein cholesterol
Measured: 10 weeks
LDL-C
Serum concentrations of low-density lipoprotein cholesterol
Measured: 10 weeks
Quality of life index (KDQOL) questionnaire
Filling the kidney disease quality of life index (KDQOL) questionnaire
Measured: 10 weeks
the Beck depression test
Filling the Beck depression test
Measured: 10 weeks
Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire
Filling the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Measured: 10 weeks
Secondary outcomes (4)
albumin
Serum concentrations of albumin
Measured: 10 weeks
calcium
Serum concentrations of calcium
Measured: 10 weeks
phosphorous
Serum concentrations of phosphorous
Measured: 10 weeks
iPTH
Serum concentrations of Intact parathyroid hormone
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion20 Jan 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zahra yari, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096558
- Sponsor's protocol ID
- 1402.034
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Movahedian M, Tabibi H, Atabak S, Hedayati M, Najafi I, Seyrafian S, Rouhani MH. Effects of melatonin on advanced glycation end products, inflammation, and oxidative stress in peritoneal dialysis patients: a randomized controlled trial. Sci Rep. 2025 Oct 22;15(1):36896. doi: 10.1038/s41598-025-20792-2.
PubMed 41125682
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Melatonin, as a Dietary Supplement, on Glycemic Parameters, Cardiovascular Disease Risk Factors, Bone Metabolism Markers and Quality of Life in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT06096558
- Acronym / sponsor ID
- 1402.034
- Conditions
- Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 23 Oct 2023 (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 aim of this double-blind randomized clinical trial is to determine the effects of Melatonin on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of advanced glycated end products and quality of life in peritoneal dialysis patients. Forty patients from peritoneal dialysis centers will randomly assign to either Melatonin or placebo group. The patients in Melatonin group will receive 5 mg Melatonin (as 1 tablet) daily for 10 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and Serum concentrations of malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; glucose; pentosidine; carboxy-methyl lysine; Procollagen 1 Intact N-Terminal Propeptide; Tartrate-resistant acid phosphatase 5b; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; lipoprotein-a; albumin; calcium; phosphorous; and also systolic blood pressure; diastolic blood pressure and questionnaires including quality of life; quality of sleep and depression will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Dietary Supplement: Melatonin |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Continuous Ambulatory Peritoneal Dialysis for 6 months or more
- Body mass index (BMI) below 35
Key exclusion criteria (3 listed)
- Infectious diseases (especially peritonitis) and inflammatory diseases Liver diseases
- Past medical history of cancer Receiving glucocorticoid drugs, non-steroidal anti-inflammatory drugs
- Receiving Melatonin supplements
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 |
|---|---|---|
| Melatonin5 mg Melatonin in one tablet, 30 minutes before night sleep | Dietary supplement | Melatonin |
| placebo1 tablet of placebo (starch) | Other | placebo |
Primary outcome
Lp (a)
Time frame: 10 weeks
Serum concentrations of lipoprotein-a
MDA
Time frame: 10 weeks
Serum concentrations of malondialdehyde
hs-CRP
Time frame: 10 weeks
Serum concentrations of high sensitivity c-reactive protein
sICAM-1
Time frame: 10 weeks
Serum concentrations of Soluble intercellular adhesion molecule-1
glucose
Time frame: 10 weeks
serum concentration of fasting glucose
pentosidine
Time frame: 10 weeks
serum concentration of pentosidine
carboxy-methyl lysine
Time frame: 10 weeks
serum concentration of carboxy-methyl lysine
P1NP
Time frame: 10 weeks
serum concentration of Procollagen 1 Intact N-Terminal Propeptide
Osteoprotegerin
Time frame: 10 weeks
Serum concentrations of Osteoprotegerin
TRACP5b
Time frame: 10 weeks
Serum concentrations of Tartrate-resistant acid phosphatase 5b
RANKL
Time frame: 10 weeks
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Systolic blood pressure
Time frame: 10 weeks
Systolic blood pressure (mmHg)
Diastolic blood pressure
Time frame: 10 weeks
Diastolic blood pressure (mmHg)
triglyceride
Time frame: 10 weeks
Serum concentrations of triglyceride
Total cholesterol
Time frame: 10 weeks
Serum concentrations of total cholesterol
HDL-C
Time frame: 10 weeks
Serum concentrations of High-density lipoprotein cholesterol
LDL-C
Time frame: 10 weeks
Serum concentrations of low-density lipoprotein cholesterol
Quality of life index (KDQOL) questionnaire
Time frame: 10 weeks
Filling the kidney disease quality of life index (KDQOL) questionnaire
the Beck depression test
Time frame: 10 weeks
Filling the Beck depression test
Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: 10 weeks
Filling the Pittsburgh Sleep Quality Index (PSQI) questionnaire
4 secondary outcomes
albumin
Time frame: 10 weeks
calcium
Time frame: 10 weeks
phosphorous
Time frame: 10 weeks
iPTH
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 41125682Movahedian M, Tabibi H, Atabak S, Hedayati M, Najafi I, Seyrafian S, Rouhani MH. Effects of melatonin on advanced glycation end products, inflammation, and oxidative stress in peritoneal dialysis patients: a randomized controlled trial. Sci Rep. 2025 Oct 22;15(1):36896. doi: 10.1038/s41598-025-20792-2.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Peritoneal Dialysis, run by National Nutrition and Food Technology Institute.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zahra yari (+982122357484, zahrayari_nut@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lp (a) (time frame: 10 weeks). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06096558, which also lists 1 linked publication.
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 23 Oct 2023.