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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027510
Receipt No. R000031531
Scientific Title Iron supplement drink intake crossover test in women with anemia or anemia tendency.
Date of disclosure of the study information 2017/11/16
Last modified on 2019/02/27

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Basic information
Public title Iron supplement drink intake crossover test in women with anemia or anemia tendency.
Acronym Anemia improvement test.
Scientific Title Iron supplement drink intake crossover test in women with anemia or anemia tendency.
Scientific Title:Acronym Anemia improvement test.
Region
Japan

Condition
Condition Healthy individual.(Those with anemia / anemia tendency that does not require treatment.)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Confirm the improvement of symptoms of anemia by orally ingesting a drink containing iron, zinc, folic acid, and calcium.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood hemoglobin value
Blood sampling should be done before the start of drink ingestion, at 2 weeks on ingestion, on the final day of ingestion (at 4 weeks of ingestion).
Key secondary outcomes Serum iron, serum folic acid, serum zinc
Blood sampling should be done before the start of drink ingestion, at 2 weeks on ingestion, on the final day of ingestion (at 4 weeks of ingestion).

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 A drink containing 7.5 mg of iron, 10.0 mg of zinc, 200 mg of calcium and 240 maicrog of folic acid was added to one drink (100 ml) per day,
Interventions/Control_2 Drinks without iron, zinc, calcium, or folic acid added 1 bottle of drink (100 ml).
Interventions/Control_3
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Those who judged that a doctor is eligible as an exam participant
Blood hemoglobin value 9.0 - 11.8 g / dl
Key exclusion criteria 1) Have a chronic illness.
2) Have serious illness, are in the hospital.
3) Taking medicines containing iron.
4) Ingesting products containing iron content.
5) Person who judged that the examining physician is inappropriate as the exam participant.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakatsu Nishikawa, M.D.,Ph.D.
Organization Mie University Hospital
Division name Clinical Research and Development Center
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-232-1111
Email nisikawa@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Umeda,Ph.D.
Organization KSK Laboratories,Inc.
Division name representative
Zip code
Address t.c.p 4F,7-15 Daimon, Tsu, Mie 514-0027, Japan
TEL 059-253-8091
Homepage URL
Email info@ksk-lab.co.jp

Sponsor
Institute Mie University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Research funds obtained from ICREO CO., LTD. are received by KSK Laboratories,Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立大学法人三重大学 総合研究棟2

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.che.tohoku.ac.jp/~scf/ouyouyakuri_top.htm
Number of participants that the trial has enrolled
Results
Hemoglobin values increased significantly after intake of the test beverage, which was the primary endpoint.  There was no change in hemoglobin values in the placebo beverage group.

The secondary endpoints, including red blood cell, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, ferritin, serum calcium, and folic acid were increased in the test beverage group. 

No adverse events were caused by intake of the beverages during the study period.
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
2017 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 27 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031531

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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