UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009069 |
|---|---|
| Receipt number | R000010644 |
| Scientific Title | Chlorella supplementation improves anemia indices and plasma homocysteine level in healthy female university students |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2012/10/09 10:37:19 |
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Basic information
Public title
Chlorella supplementation improves anemia indices and plasma homocysteine level in healthy female university students
Acronym
Chlorella supplementation improves anemia indices and plasma homocysteine level in healthy female university students
Scientific Title
Chlorella supplementation improves anemia indices and plasma homocysteine level in healthy female university students
Scientific Title:Acronym
Chlorella supplementation improves anemia indices and plasma homocysteine level in healthy female university students
Region
| Japan |
Condition
Condition
young female
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Iron intake from meals is insufficient to meet anemia nutritional status in young women. Chlorella is algae food which contains various nutrients, including iron, folate, vitamin B12, etc. This study was conducted to confirm the improvement effects to the anemia indicators of female university students by 12 weeks of Chlorella supplementation using randomized, dose-response, parallel-group trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ferritin, transferrin, Hb, RBC, MCV, MCH, MCHC, serum iron
Key secondary outcomes
serum folate, Total homocystein
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Receive 0.6 g / day of Chlorella for 12 weeks.
Interventions/Control_2
Receive 3.0 g / day of Chlorella for 12 weeks.
Interventions/Control_3
Receive 6.0 g / day of Chlorella for 12 weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Female students in third grade or second grade of the School of Nutrition & Dietetics, KANAGAWA UNIVERSITY OF HUMAN SERVICES
Key exclusion criteria
1)Subjects with drug and food allergy.
2)Subjects taking supplements such as chlorella foods, iron and folic acid on a daily basis.
3)Recipients of antithrombotic medication such as a warfarin.
4)Smokers.
5)Subjects judged to be ineligible for the participation in this clinical trial by a doctor
helping the research as a consequence of the screening.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gomi Ikuko |
Organization
School of Nutrition & Dietetics, KANAGAWA UNIVERSITY OF HUMAN SERVICES
Division name
Graduate Course of Health and Social Services
Zip code
Address
Yokosuka Heisei-cho 1-10-1 Kanagawa Japan
TEL
046-828-2666
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Gomi Ikuko |
Organization
School of Nutrition & Dietetics, KANAGAWA UNIVERSITY OF HUMAN SERVICES
Division name
Graduate Course of Health and Social Services
Zip code
Address
Yokosuka Heisei-cho 1-10-1 Kanagawa Japan
TEL
046-828-2666
Homepage URL
gomi-i@kuhs.ac.jp
Sponsor or person
Institute
School of Nutrition & Dietetics, KANAGAWA UNIVERSITY OF HUMAN SERVICES
Institute
Department
Personal name
Funding Source
Organization
Sun Chlorella
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神奈川県立保健福祉大学
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
2012 ESPEN
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2011 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 09 | Day |
Last modified on
| 2012 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010644
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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