HealthyNCT01751204
Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water
A study testing Calcium tablet, Calcium ion water (250mg) and Calcium ion water (125mg) in people with Healthy, run by Hiroshima University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion water. Read more about this study
- Who is it for?
- Ages 55 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Calcium tablet, Calcium ion water (250mg) and Calcium ion water (125mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal females
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Calcium tablet, Calcium ion water (250mg), Calcium ion water (125mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium tabletDietary supplement
Calcium ion water (250mg)Dietary supplement
Calcium ion water (125mg)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Calcium tablet | Active comparator | 250 mg calcium/tablet Receives: Dietary Supplement: Calcium tablet |
| Calcium ion water (250mg) | Experimental | 250 mg calcium in 200 ml water Receives: Dietary Supplement: Calcium ion water (250mg) |
| Calcium ion water (125mg) | Experimental | 125 mg calcium in 200 ml water Receives: Dietary Supplement: Calcium ion water (125mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum calcium profile (including AUC, Cmax, and Tmax)
Measured: Overall 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- CHUGOKU KAYAKU CO., LTD.
- Responsible party
- Principal investigator, Fumiko Higashikawa, Hiroshima University
- Investigators
- Fumiko Higashikawa, PhD, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751204
- Sponsor's protocol ID
- eki-677
- Status last verified
- Mar 2013
- First submitted
- 13 Dec 2012
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Crossover Study to Compare the Absorbability Between Calcium Tablet and Calcium Ion Water
- ClinicalTrials.gov ID
- NCT01751204
- Acronym / sponsor ID
- eki-677
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- CHUGOKU KAYAKU CO., LTD.
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion water.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium tablet | Active comparator | Dietary Supplement: Calcium tablet250 mg calcium/tablet |
| Calcium ion water (250mg) | Experimental | Dietary Supplement: Calcium ion water (250mg)250 mg calcium in 200 ml water |
| Calcium ion water (125mg) | Experimental | Dietary Supplement: Calcium ion water (125mg)125 mg calcium in 200 ml water |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal females
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium tablet | Dietary supplement | Calcium tablet |
| Calcium ion water (250mg) | Dietary supplement | Calcium ion water (250mg) |
| Calcium ion water (125mg) | Dietary supplement | Calcium ion water (125mg) |
Primary outcome
Serum calcium profile (including AUC, Cmax, and Tmax)
Time frame: Overall 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fumiko Higashikawa, PhD principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium tablet, Calcium ion water (250mg) and Calcium ion water (125mg) in people with Healthy, run by Hiroshima University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum calcium profile (including AUC, Cmax, and Tmax) (time frame: Overall 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.