NCT01751204

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 28, 2013

Status Verified

March 1, 2013

Enrollment Period

3 months

First QC Date

December 13, 2012

Last Update Submit

March 26, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Serum calcium profile (including AUC, Cmax, and Tmax)

    Overall 2 hours

Study Arms (3)

Calcium tablet

ACTIVE COMPARATOR

250 mg calcium/tablet

Dietary Supplement: Calcium tablet

Calcium ion water (250mg)

EXPERIMENTAL

250 mg calcium in 200 ml water

Dietary Supplement: Calcium ion water (250mg)

Calcium ion water (125mg)

EXPERIMENTAL

125 mg calcium in 200 ml water

Dietary Supplement: Calcium ion water (125mg)

Interventions

Calcium tabletDIETARY_SUPPLEMENT
Calcium tablet
Calcium ion water (250mg)DIETARY_SUPPLEMENT
Calcium ion water (250mg)
Calcium ion water (125mg)DIETARY_SUPPLEMENT
Calcium ion water (125mg)

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal females

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, 734-8551, Japan

Location

MeSH Terms

Interventions

Calcium

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Fumiko Higashikawa, PhD

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 17, 2012

Study Start

November 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 28, 2013

Record last verified: 2013-03

Locations

JP(1)