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Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water

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ClinicalTrials.gov Identifier: NCT01751204
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : March 28, 2013
Sponsor:
Collaborator:
CHUGOKU KAYAKU CO., LTD.
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University

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

Condition or disease Intervention/treatment
Healthy Dietary Supplement: Calcium tablet Dietary Supplement: Calcium ion water (250mg) Dietary Supplement: Calcium ion water (125mg)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Crossover Study to Compare the Absorbability Between Calcium Tablet and Calcium Ion Water
Study Start Date : November 2012
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Calcium tablet
250 mg calcium/tablet
Dietary Supplement: Calcium tablet
Experimental: Calcium ion water (250mg)
250 mg calcium in 200 ml water
Dietary Supplement: Calcium ion water (250mg)
Experimental: Calcium ion water (125mg)
125 mg calcium in 200 ml water
Dietary Supplement: Calcium ion water (125mg)



Primary Outcome Measures :
  1. Serum calcium profile (including AUC, Cmax, and Tmax) [ Time Frame: Overall 2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751204


Locations
Japan
Hiroshima University
Hiroshima,, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
CHUGOKU KAYAKU CO., LTD.
Investigators
Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University

Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01751204     History of Changes
Other Study ID Numbers: eki-677
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs