The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients
Launched by NATIONAL NUTRITION AND FOOD TECHNOLOGY INSTITUTE · Oct 21, 2023
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to understand how Melatonin, a natural hormone that helps regulate sleep, may affect heart health and bone health in patients who are on peritoneal dialysis. The study will involve 40 patients who will be divided into two groups: one group will receive Melatonin (5 mg daily for 10 weeks) while the other group will receive a placebo, which is a pill that looks the same but does not contain Melatonin. Researchers want to see if Melatonin can improve risk factors for heart disease, bone metabolism, and overall quality of life for these patients.
To participate in this trial, individuals must have been on peritoneal dialysis for at least six months and have a body mass index (BMI) below 35. Participants will need to provide blood samples before and after the study to check for various health markers related to heart and bone health. They will also complete surveys about their quality of life, sleep, and mood. It's important to note that people with certain health conditions, like infections or cancer, or those taking specific medications, may not be eligible to participate. This study is not yet recruiting participants, so there will be more information available soon for those who are interested.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Continuous Ambulatory Peritoneal Dialysis for 6 months or more
- • Body mass index (BMI) below 35
- Exclusion Criteria:
- • 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
About National Nutrition And Food Technology Institute
The National Nutrition and Food Technology Institute is a leading research organization dedicated to advancing the fields of nutrition and food science through innovative clinical trials and studies. Committed to enhancing public health, the Institute focuses on developing evidence-based interventions and policies that address nutritional challenges and promote optimal dietary practices. With a multidisciplinary team of experts, the Institute collaborates with various stakeholders, including academic institutions, government agencies, and industry partners, to foster research excellence and translate findings into practical applications that benefit communities nationwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported