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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01751204
Other study ID # eki-677
Secondary ID
Status Completed
Phase N/A
First received December 13, 2012
Last updated March 26, 2013
Start date November 2012
Est. completion date February 2013

Study information

Verified date March 2013
Source Hiroshima University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion water.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 55 Years to 70 Years
Eligibility Inclusion Criteria:

- Postmenopausal females

Exclusion Criteria:

- Taking medicines or functional food that affect serum calcium levels

- Diseases that affect bone

- Renal or hepatic dysfunction

- Heart disease

- Participation in any clinical trial within 90 days of the commencement of the trial

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Calcium tablet

Calcium ion water (250mg)

Calcium ion water (125mg)


Locations

Country Name City State
Japan Hiroshima University Hiroshima,

Sponsors (2)

Lead Sponsor Collaborator
Hiroshima University CHUGOKU KAYAKU CO., LTD.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum calcium profile (including AUC, Cmax, and Tmax) Overall 2 hours No
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