UMIN-CTR Clinical Trial

Public title

Measurement of calcium concentrations in serum and a single hair shaft

Acronym

Measurement of Ca concentrations in serum and a single hair shaft

Scientific Title

Measurement of calcium concentrations in serum and a single hair shaft

Scientific Title:Acronym

Measurement of Ca concentrations in serum and a single hair shaft

Region

Japan

Condition

Healthy men and women who are younger than 40 years in age.

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The cells of hair root make a hair by utilizing various kinds of nutrition through blood. A hair records the inflow of nutrition including calcium along a single hair shaft. The contents of nutrition along a hair shaft can be measured by X - ray fluorescence using synchrotron radiation at institutes like Spring - 8 in Japan. It is reported that the inflow of calcium into cancer cells reaches fivefold in comparison with an ordinary level when cancer occurs, and declines gradually as cancer grows. It can be possible to predict cancer occurrence at an early stage if calcium concentration is analyzed along a hair shaft. The purpose of this study is to know average calcium concentrations in serum and a single hair shaft of healthy man and woman.

Basic objectives2

Others

Basic objectives -Others

1. Five men and women who are younger than 40 years old take 6 calcium capsules (150 mg each) per day for two weeks. A blood sample (3 ml) is taken on the first day before taking calcium capsules and on the 14th day after taking those. The serums are kept frozen at minus 20 degree centigrade until the measurement. Two hairs are collected on the 14th day.
2. Calcium concentrations in the dried serum and hair are measured by X ray fluorescence using synchrotron radiation. The relationship between concentrations of serum calcium and calcium of a hair root cell before and after calcium intake is analyzed.
3. Calcium capsules are supplied by by Fujix inc. in Japan.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The relationship of calcium concentrations between serum and hair shafts of healthy men and women who are younger than 40 years old.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

1. Five men and five women who are healthy and do not take medicines regularly take 900 mg calcium (3ACa) per day in t i d for two weeks. A blood sample of 3 ml is taken on the first day, and the 14th day. Two hairs are collected on the 14th day.
2. The calcium concentrations of dried serum and hair shafts before and after calcium intake are measured by X-ray fluorescence using synchrotron radiation.
3. Calcium capsules (3A calcium) are supplied by Fujix inc. in Japan.
4. The term is 60 days. Trial starts on January 30, 2011 and ends March 31, 2011.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

40

years-old

>=

Gender

Male and Female

Key inclusion criteria

Male and female who are healthy and do not take medicines regularly.

Key exclusion criteria

1 Men and women who feel unhealthy in a daily life.
2 Men and women who are treated by medical doctors.
3 Men and women who have heart diseases.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Hiroki Shima, M.D. Ph.D.

Organization

The SHIMA Institution for Quantum Medicine

Division name

Division of Clinical Trial

Zip code

Address

3-7-41-401 Nakatsu Kitaku Osaka JAPAN 531-0071

TEL

+81-6-6372-8755

Email

shima@siqm.org

Name of contact person

1st name
Middle name
Last name	Hiroki Shima

Organization

The SHIMA Institution for Quantum MedicineMedicine

Division name

Division of Clinical Trial

Zip code

Address

3-7-41-401 Nakatsu Kitaku Osaka JAPAN 531-0071

TEL

+81-6-6372-8755

Homepage URL

Email

shima@siqm.org

Institute

The SHIMA Institution for Quantum Medicine

Institute

Department

Personal name

Organization

The SHIMA Institution for Quantum MedicineMedicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Center for Advanced Science and Technology, Hyogo

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

島こどもクリニック（大阪府） Shima Children Clinic (Osaka, JAPAN)

Date of disclosure of the study information

2011

Year

01

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Elemental concentrations in hair and dried serum from 5 female and 5 male healthy subjects under continuous intake of Calcium (Ca) capsule (900 mg daily) for 14 days have been observed by X-ray fluorescence analysis with the definition of relative concentration free from specimen thickness. The dried serum samples from the10 test subjects with Ca supplementation for 2 weeks showed the same relative concentration for each of elements such as Ca, Cl, K, S and P under the renal control by parathyroid hormone (PTH). X-ray fluorescence analysis of these 10 test subjects showed that 8 out of 10 had DA type (one of hair Ca metabolism types with lower hair Ca concentration than normal range of hair Ca), 2 out of 10 had LD type (long-term Ca channel gating with Ca deficiency) and LD type suspected. Elements in the dried serum were all normalized with Ca intake for 2 weeks, although there were some test subjects whose elements in the hair were not normalized. Hair element concentrations have also been measured in 50 randomly-selected females aged between 30s and 70s. The results showed that each element has two separate levels, with a relatively higher and lower concentration of elements. The elements in growing hair in a steady state must depend on the inflow of elements into the hair matrix cells on hair root from serum. Using this principle, the two concentration levels can be attributed to gating and closing of the ion channels in cell membrane and are proportional to the standard concentrations of the dried serum. By analyzing elements in the hair and dried serum of 5 normal men and women by x-ray fluorescence analysis under continuous intake of Ca for 2 weeks, Ca metabolism type can be detected and it may be possible to reduce cancer risk by taking Ca every day in a person who shows LD type (long-term Ca channel gating with Ca deficiency).

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

Recruitment status

Main results already published

Date of protocol fixation

2011

Year

01

Month

07

Day

Date of IRB

Anticipated trial start date

2011

Year

01

Month

01

Day

Last follow-up date

2011

Year

03

Month

01

Day

Date of closure to data entry

2011

Year

03

Month

01

Day

Date trial data considered complete

2011

Year

08

Month

01

Day

Date analysis concluded

2011

Year

12

Month

01

Day

Other related information

Registered date

2011

Year

01

Month

28

Day

Last modified on

2015

Year

07

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005870