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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014