Unique ID issued by UMIN | UMIN000028425 |
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Receipt number | R000032419 |
Scientific Title | A clinical research to measure blood concentrations of vitamin A and vitamin C in patients with chronic kidney disease multicenter, prospective observational research |
Date of disclosure of the study information | 2017/07/31 |
Last modified on | 2020/09/11 11:07:05 |
A clinical research to measure blood concentrations of vitamin A and vitamin C in patients with chronic kidney disease
multicenter, prospective observational research
A clinical research to measure blood concentrations of vitamins in patients with chronic kidney disease
A clinical research to measure blood concentrations of vitamin A and vitamin C in patients with chronic kidney disease
multicenter, prospective observational research
A clinical research to measure blood concentrations of vitamins in patients with chronic kidney disease
Japan |
Chronic kidney disease (CKD)
Nephrology | Urology |
Others
NO
To measure blood concentrations of vitamin A and vitamin C in patients with chronic kidney disease
Others
Blood concentrations of vitamin A and vitamin C
Blood concentrations of vitamin A
Blood concentrations of vitamin C
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Common to study 1, study 2 and study 3
(1)Patients aged 20 years or older on the date of informed consent.
(2)Patients who are able to provide written informed consent or whose legally acceptable representative is able to provide written informed consent.
(3)Patients who have not undergone any surgery within 1 week before the day of providing informed consent.
Common to study 1 and study 2
(1)Patients who are graded as G3b, G4, or G5 according to the severity classification of CKD or have received stable hemodialysis or hemodiafiltration 3 times a week.
Only for study 1
(1)Patients who do not receive TPN at the time of providing informed consent.
Only for study 2
(1)Patients who receive TPN at the time of providing informed consent.
Only for study 3
(1)Patients who have received stable hemodialysis or hemodiafiltration 3 times a week.
(2)Patients who do not receive TPN at the time of providing informed consent and planned to receive TPN with multivitamins for total parenteral nutrition every day at fasting from the day of initiation of TPN to third hemodialysis.
(1)Patients who have taken any supplement containing vitamin A and vitamin C from the day of providing informed consent to enrollment.
(2)Patients with severe hepatic impairment.
(3)Patients with hepatic coma or with a risk of hepatic coma.
(4)Pregnant or lactating women
(5)Patients who received blood sampling of more than 200 mL within 4 weeks before the date of informed consent and patients who received blood sampling of more than 400 mL within 16 weeks before the date of informed consent (in all cases, blood domination is included and blood collection for autologous blood transfusion is excluded).
(6)Patients who participated in a clinical trial or clinical research where a drug is administered to patients, within 16 weeks before the date of informed consent.
(7)Other patients who have been determined as ineligible by the investigator.
80
1st name | Tatsukuni |
Middle name | |
Last name | Kawakami |
Otsuka Pharmaceutical Factory, Inc.
Clinical Development Department, Research and Development Center
101-0052
5F Nikko Kanda Building, 1-1 Ogawa-machi, Kanda, Chiyoda-ku, Tokyo
03-5280-2721
Kawakami.Tatsukuni@otsuka.jp
1st name | Tatsukuni |
Middle name | |
Last name | Kawakami |
Otsuka Pharmaceutical Factory, Inc.
Clinical Development Department, Research and Development Center
101-0052
5F Nikko Kanda Building, 1-1 Ogawa-machi, Kanda, Chiyoda-ku, Tokyo
03-5280-2721
Kawakami.Tatsukuni@otsuka.jp
Otsuka Pharmaceutical Factory, Inc.
Otsuka Pharmaceutical Factory, Inc.
Profit organization
Non-Profit Organization MINS Institutional Review Board
20-9-401, Mita, 5-chome, Minato-ku, Tokyo, Japan
03-6416-1868
npo-mins@j-irb.com
NO
2017 | Year | 07 | Month | 31 | Day |
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000032419
Published
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000032419
62
Blood concentrations of vitamin A and vitamin C in few CKD patients at predialysis and maintenance dialysis stages deviated from the upper limit of reference value.
This result showed the necessity of appropriate supplementation of vitamin A and vitamin C for such patients.
2020 | Year | 09 | Month | 11 | Day |
Study 1
man:21
woman:17
age
20-34 years old:2
35-49 years old:3
50-64 years old:9
65 or more:24
Study 2
man:11
woman:3
age
50-64 years old:1
65 years old or more:13
Study 3
man:7
woman:3
age
50-64 years old:3
65 years old or more:7
Study 1:38
Study 2:14
Study 3:10
-
Blood concentrations of vitamin A
Blood concentrations of vitamin C
Completed
2017 | Year | 05 | Month | 31 | Day |
2017 | Year | 06 | Month | 26 | Day |
2017 | Year | 07 | Month | 27 | Day |
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 06 | Month | 30 | Day |
Type of clinical research
Multicenter, prospective observational research with minimum invasion
Study subjects
Study 1: CKD patients without TPN
Study 2: CKD patients with TPN
Study 3: maintenance hemodialysis patients who are planned to receive TPN
Method of study subject recruitment
After conclusion of contract with each test site, written informed consent for participation in the study is obtained from the subject or the subject's legally acceptable representative. Study subjects are the patients who are treated in any of the study sites by December 30, 2017, meet all of the inclusion criteria, and do not come under any of the exclusion criteria.
Outcomes
Blood concentrations of vitamin A and vitamin C
The target number of study subjects
80 subjects at most
Study 1: 40 subjects (20 of them are the patients with predialysis chronic kidney disease and 20 of them are dialysis patients)
Study 2: 20 subjects (10 of them are the patients with predialysis chronic kidney disease and 10 of them are dialysis patients)
Study 3: 20 subjects
When the number of study subjects of study 3 reaches 10, the study can be completed even if the number of study subjects of study 1 and study 2 do not reach the target number.
2017 | Year | 07 | Month | 28 | Day |
2020 | Year | 09 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032419
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