UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027510 |
|---|---|
| Receipt number | 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 11:30:50 |
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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
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
info@ksk-lab.co.jp
Sponsor or person
Institute
Mie University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031531
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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