UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015978
Receipt number R000018583
Scientific Title Establishment of assay system for zinc in whole blood
Date of disclosure of the study information 2014/12/17
Last modified on 2018/12/19 16:17:14

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Basic information

Public title

Establishment of assay system for zinc in whole blood

Acronym

Assay system for zinc

Scientific Title

Establishment of assay system for zinc in whole blood

Scientific Title:Acronym

Assay system for zinc

Region

Japan


Condition

Condition

Zinc deficiency

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Plasma zinc level is assayable,but total zinc stored in whole body is not measurable,yet. In order to estimate stored zinc in whole body, we would like to establish to assay zinc in red blood cells.

Basic objectives2

Others

Basic objectives -Others

Zinc level in plasma and red blood cells will be measured befor and after uptake of zinc supplement.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Zinc content in red blood cells can be measured using the assay system for plasama zinc.

Key secondary outcomes

After uptake of zinc supplement, zinc contents in both plasma and red cells demonstrate increment.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

To intake zinc-containing supplement.Seven days, at the regular supplement doses.

Interventions/Control_2

To draw peripheral blood before and after the inake of zinc supplement.
About 15 ml for blood cell count,chemistry and zinc level measurement.

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

Nothing

Key exclusion criteria

Nothing

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Ikebuchi

Organization

Saitama Medical University International Medical Center

Division name

Laboratory Department

Zip code


Address

1397-1, Yamane, Hidaka City, Saitama, Japan

TEL

042-984-4383

Email

ikebuchi@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Ikebuchi

Organization

Saitama Medical University International Medical Center

Division name

Laboratory Medicine Department

Zip code


Address

1397-1,Yamane, Hidaka City, Saitama

TEL

042-984-4383

Homepage URL


Email

ikebuchi@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Nothing

Name of secondary funder(s)

Nothing


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



Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

After lyzing total blood and red blood cells, supernatant solution samples were analysed its zinc content. The red color of the samples disturbed the colorimetoric assay and 20x dilution was necessary to assay. The intake of zinc supplement did not induced the increase of zinc storage volume in red blood cells and total blood. Seven days intake was not sufficient.

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

2014 Year 09 Month 03 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 17 Day

Last follow-up date

2015 Year 08 Month 31 Day

Date of closure to data entry

2015 Year 08 Month 31 Day

Date trial data considered complete

2015 Year 08 Month 31 Day

Date analysis concluded

2016 Year 01 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 12 Month 17 Day

Last modified on

2018 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018583


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name