- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01751204
Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water
March 26, 2013 updated by: Fumiko Higashikawa, Hiroshima University
A Randomized, Double-blind, Crossover Study to Compare the Absorbability Between Calcium Tablet and Calcium Ion Water
The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion water.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hiroshima,, Japan, 734-8551
- Hiroshima University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Calcium tablet
250 mg calcium/tablet
|
|
|
Experimental: Calcium ion water (250mg)
250 mg calcium in 200 ml water
|
|
|
Experimental: Calcium ion water (125mg)
125 mg calcium in 200 ml water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum calcium profile (including AUC, Cmax, and Tmax)
Time Frame: Overall 2 hours
|
Overall 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
December 13, 2012
First Submitted That Met QC Criteria
December 13, 2012
First Posted (Estimate)
December 17, 2012
Study Record Updates
Last Update Posted (Estimate)
March 28, 2013
Last Update Submitted That Met QC Criteria
March 26, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- eki-677
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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