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Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water

This study has been completed.
Sponsor:
Collaborator:
CHUGOKU KAYAKU CO., LTD.
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University
ClinicalTrials.gov Identifier:
NCT01751204
First received: December 13, 2012
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Dietary Supplement: Calcium tablet
Dietary Supplement: Calcium ion water (250mg)
Dietary Supplement: Calcium ion water (125mg)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Serum calcium profile (including AUC, Cmax, and Tmax) [ Time Frame: Overall 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   55 Years to 70 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01751204     History of Changes
Other Study ID Numbers: eki-677
Study First Received: December 13, 2012
Last Updated: March 26, 2013
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013