A clinical research to measure blood concentrations of vitamin A and vitamin C in patients with chronic kidney disease multicenter, prospective observational research

UMIN ID: UMIN000028425

Registered date:31/07/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic kidney disease (CKD)
• Date of first enrollment: 2017/07/27
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Blood concentrations of vitamin A
• Secondary Outcome: Blood concentrations of vitamin C

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (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.

Related Information

• Primary Sponsor: Otsuka Pharmaceutical Factory, Inc.
• Source(s) of Monetary Support: Otsuka Pharmaceutical Factory, Inc.