An interventional study of Melatonin and placebo in Peritoneal Dialysis, sponsored by National Nutrition and Food Technology Institute. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by National Nutrition and Food Technology Institute · Not applicable, Interventional, and Treatment
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.
National Nutrition and Food Technology Institute is the lead sponsor of 63 studies on the registry; 7 are open to participants now.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Melatonin
Other: placebo
5 mg Melatonin in one tablet, 30 minutes before night sleep
1 tablet of placebo (starch)
Lp (a)
Serum concentrations of lipoprotein-a
Time frame: 10 weeks
MDA
Serum concentrations of malondialdehyde
Time frame: 10 weeks
hs-CRP
Serum concentrations of high sensitivity c-reactive protein
Time frame: 10 weeks
sICAM-1
Serum concentrations of Soluble intercellular adhesion molecule-1
Time frame: 10 weeks
glucose
serum concentration of fasting glucose
Time frame: 10 weeks
pentosidine
serum concentration of pentosidine
Time frame: 10 weeks
carboxy-methyl lysine
serum concentration of carboxy-methyl lysine
Time frame: 10 weeks
P1NP
serum concentration of Procollagen 1 Intact N-Terminal Propeptide
Time frame: 10 weeks
Osteoprotegerin
Serum concentrations of Osteoprotegerin
Time frame: 10 weeks
TRACP5b
Serum concentrations of Tartrate-resistant acid phosphatase 5b
Time frame: 10 weeks
RANKL
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Time frame: 10 weeks
Systolic blood pressure
Systolic blood pressure (mmHg)
Time frame: 10 weeks
Diastolic blood pressure
Diastolic blood pressure (mmHg)
Time frame: 10 weeks
triglyceride
Serum concentrations of triglyceride
Time frame: 10 weeks
Total cholesterol
Serum concentrations of total cholesterol
Time frame: 10 weeks
HDL-C
Serum concentrations of High-density lipoprotein cholesterol
Time frame: 10 weeks
LDL-C
Serum concentrations of low-density lipoprotein cholesterol
Time frame: 10 weeks
Quality of life index (KDQOL) questionnaire
Filling the kidney disease quality of life index (KDQOL) questionnaire
Time frame: 10 weeks
the Beck depression test
Filling the Beck depression test
Time frame: 10 weeks
Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire
Filling the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: 10 weeks
albumin
Serum concentrations of albumin
Time frame: 10 weeks
calcium
Serum concentrations of calcium
Time frame: 10 weeks
phosphorous
Serum concentrations of phosphorous
Time frame: 10 weeks
iPTH
Serum concentrations of Intact parathyroid hormone
Time frame: 10 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin
National Nutrition and Food Technology Institute