臨床研究等提出・公開システム

Date of registration	Jan. 20, 2020
Last modified on	Mar. 31, 2022
Trial ID	jRCTs041190107

Scientific Title	Mesurement of blood levels of orally-administered Nicotinamide Powder 10% Zonne and its NAD+ pathway metabolites
Public Title	Measurement of NAD+ metabolites in blood after oral intake of Vitamin B3

Completion date	Feb. 21, 2020
Result actual enrolment	6
Baseline Characteristics	6 men at the median age of 29 years old with no abnormality in prescreening
Participant flow	6 completed the low-dose study, 5 of which completed the high-dose study as well.
Adverse events	None
Outcome measures	Blood NAD+ levels significantly increased 12 h after 500 mg nicotinamide intake
Brief summary	Oral intake of 500 mg nicotinamide raised blood NAD+ levels in healthy men
Date of posting of results summaries	Mar. 31, 2022

Plan to share IPD	No
Plan description	Not Applicable
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs041190107

Contact for Scientific Queries	Name	Sato Tomohito
	Affiliation	Hamamatsu University Hospital
	Address	1-20-1,Handayama,Higashiku,Hamamatsu,Shizuoka
	Telephone	+81-53-435-2111
	E-mail	titon0620@gmail.com
Contact for Public Queries	Name	Ito Takashi
	Affiliation	RIKEN
	Address	2-1,Hirosawa,Wako,Saitama
	Telephone	+81-48-467-9516
	E-mail	itotakakun77777@gmail.com

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 20, 2020
Actual date of first enrollment		Jan. 24, 2020
Target sample size		6
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	dose comparison control
	assignment	crossover assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	1. Healthy adults between ages of 20 years old and 80 years old 2. Those who gaven written consent to study
	Exclusion Criteria	1. Current use of medications and supplements including Vitamin B3 2. Pregnancy 3. Lactation 4. Current use of medications 5. Any other conditions medical doctors find inadequate to participate in study
	Age Minimum	20age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		N/A
Intervention(s)		1st: Meassure levels of Nicotinamide and NAD+ metabolites after oral supplementation of 100 mg Nicotinamide Powder 10% Zonne 2nd: Meassure levels of Nicotinamide and NAD+ metabolites after oral supplementation of 500 mg Nicotinamide Powder 10% Zonne
Primary Outcome(s)		Pharmacokinetics of NAD+ as the changed form of supplemented nicotinamide
Secondary Outcome(s)		Pharmacokinetics of nicotinamide Safety assessment mainly for liver functions

Name of Certified Review Board	Clinical Research Review Board of Hamamatsu University School of Medicine
Address	1-20-1,Handayama,Higashiku,Hamamatsu,Shizuoka, Shizuoka
Telephone	+81-53-435-2680
E-Mail	kenkyou.s@hama-med.ac.jp
Approval Status	Approval
Date of approval	Jan. 07, 2020

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Mar. 31, 2022	(this page)	Changes
3	April. 22, 2020	Detail	Changes
2	Feb. 26, 2020	Detail	Changes
1	Jan. 20, 2020	Detail

List of change history