Dialysis Patients
Conditions
Interventions
One bottle (50 ml) of the nutrients supplement "
AMP01"
is to be administered three times a week just after hemodialysis sessions for 12 weeks. The test food is lightly yellow drink containing carnitine 500mg, CoQ10 30mg, oligosaccharide 5g, zinc 8mg, vit
Sponsors
Osaka City University Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who are equal or more than 30-year-old and less than 70 year-old at the time of getting the Informed consent (2) Patients undergoing regular afternoon or night hemodialysis (3) Hemodialysis duration is more than one year (4) Patients who receive hemodialysis three times a week (5) Patients who are capable of understanding the study, and those who can give written informed consents (6) Patients who can adhere instructions
Exclusion criteria
Exclusion criteria: (1) Patients who are taking nutrients supplements. If the patients can stop taking the supplements two weeks before the study, the patients do not meet exclusion criteria. (2) Patients who receive vitamin compound (except Vitamin D) for treatment, or take OTC drugs for vitamine supplementation. If the patients can stop the treatment two weeks before the study, the patients do not meet exclusion criteria. (3) During the pregnancy or nursing , or patients to be pregnant during the study period (4) patients who participated in other clinical trials for food or drug within the past three months (5)Patients with allergy against constituents of the supplement (6) Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceleration plethysmogram, fatigue markers (alpha-MSH, ACTH, cortisol, HHV6, 7), questionnaires for acute and chronic fatigue, questionnaires for QOL (KDQOL-SF). | — |
Countries
Japan
Contacts
Public ContactHisako Fujii
Osaka City University Hospital Center for Drug & Food Clinical Evaluation
Outcome results
None listed