PostmenopausePhase 1/2NCT01338142
Amorphous Calcium Carbonate (Acc) Versus Crystalline Calcium Carbonate (Ccc) Using Stable Calcium Isotopes In Postmenopausal Women
A Phase 1/2 study testing CCC and ACC in people with Postmenopause, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The study objective is, to evaluate the fractional absorption of calcium from amorphous calcium carbonate (ACC) Vs crystalline calcium carbonate (CCC) dietary supplements in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause
- What is being tested?
- CCC and ACC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- May 2011to Jul 2012
- Phase
- Phase 1/2
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L
- BMI 18-29 (inclusive)
- Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects who provide written informed consent to participate in the study.
Who cannot join
- Women who, on the basis of a food frequency questionnaire, have an estimated daily calcium intake >1100 mg through combined diet (both supplements and food).
- Women with vitamin D deficiency < 30 ng/ml
- Women with hypercalcemia, nephrolithiasis, inflammatory bowel disease, malabsorption, chronic diarrhea, use of antibiotics within the past month, Woman suffering from digestive, hepatic, renal, or inflammatory diseases.
- Women who take oral steroids, anticonvulsants, bisphosphonates, estrogen compounds, calcitonin, or teriparatide within the past 6 months.
- Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator (PI).
- Subjects who are non-cooperative or unwilling to sign consent form.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Medical Center
Tel Aviv
Nachum Vaisman, Professor, 00-972-3-6974807, vaisman@tasmc.health.gov.il
About this study
Official title: A Randomised, Double-Blind, Crossover Bioavailability Study Comparing Amorphous Calcium Carbonate (Acc) Versus Crystalline Calcium Carbonate (Ccc) Using Stable Calcium Isotopes In Postmenopausal Women
The study objective is, to evaluate the fractional absorption of calcium from amorphous calcium carbonate (ACC) Vs crystalline calcium carbonate (CCC) dietary supplements in postmenopausal women.
Read the detailed description
This is a randomized, double-blind, crossover bioavailability study comparing the fractional absorption of calcium from amorphous calcium carbonate (ACC) versus crystalline calcium carbonate (CCC) using stable calcium isotopes in postmenopausal women.
The study is comprised of 15 subjects orally administered immediately after breakfast a 600 mg gelatin capsules containing either 600 mg (2 capsules of 300 mg)of ACC (192 mg elemental calcium) of 480 mg CCC (192 mg elemental calcium), labeled with 15 mg of 44Ca (2 capsules of 300 mg).
Five minutes following the oral administration, each subject will be infused intravenously with 1.5 mg of CaCl2 labeled with 42Ca over 10 min. Over the following 24 h subjects will consume meals that will be selected by the Unit of Clinical Nutrition at Sourasky Medical Center nutritionist on the basis of their food diary and ALL urine excreted during this time should be collected in a designated urine container and returned to the Unit of Clinical Nutrition at Sourasky Medical Center for evaluation. The same protocol as in day 0 with a crossover oral treatment will be performed after 21 day washout period.
Dosing day will be designated "Day 0". Eligible subjects are randomly assigned to one of the study treatments according to the following regimens:
- Conditions
- Postmenopause
- Being tested
- CCC, ACC
- Keywords
- postmenopausal, women, absorption, calcium, amorphous calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCCOther
600 mg (2 capsules of 300 mg) for oral use of 480 mg CCC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca and 120 mg of inactive filler, sucrose.
1.5 mg of 42Ca labeled CaCl2 through IV injection
ACCOther
600 mg (2 capsules of 300 mg) for oral use containing 600 mg ACC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca 1.5 mg of 42Ca labeled CaCl2 through IV injection
| Study group | Role | What they receive |
|---|---|---|
| CCC | Placebo comparator | Crystalline calcium carbonate (CCC) Receives: Other: CCC |
| ACC | Experimental | Amorphous calcium carbonate (ACC) Receives: Other: ACC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in fractional absorption of calcium from amorphous calcium carbonate (ACC) Vs. crystalline calcium carbonate (CCC).
Fractional absorption will be evaluated by measuring 42Ca and 44Ca levels in the urine over 24 hours (the ratio)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Amorphical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338142
- Sponsor's protocol ID
- TASMC-10-NV-571-CTIL
- Status last verified
- Mar 2011
- First submitted
- 13 Apr 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Crossover Bioavailability Study Comparing Amorphous Calcium Carbonate (Acc) Versus Crystalline Calcium Carbonate (Ccc) Using Stable Calcium Isotopes In Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01338142
- Acronym / sponsor ID
- TASMC-10-NV-571-CTIL
- Conditions
- Postmenopause
- Keywords
- postmenopausal, women, absorption, calcium, amorphous calcium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Amorphical Ltd.
- Study start
- May 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 19 Apr 2011 (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 study objective is, to evaluate the fractional absorption of calcium from amorphous calcium carbonate (ACC) Vs crystalline calcium carbonate (CCC) dietary supplements in postmenopausal women.
Detailed description
This is a randomized, double-blind, crossover bioavailability study comparing the fractional absorption of calcium from amorphous calcium carbonate (ACC) versus crystalline calcium carbonate (CCC) using stable calcium isotopes in postmenopausal women.
The study is comprised of 15 subjects orally administered immediately after breakfast a 600 mg gelatin capsules containing either 600 mg (2 capsules of 300 mg)of ACC (192 mg elemental calcium) of 480 mg CCC (192 mg elemental calcium), labeled with 15 mg of 44Ca (2 capsules of 300 mg).
Five minutes following the oral administration, each subject will be infused intravenously with 1.5 mg of CaCl2 labeled with 42Ca over 10 min. Over the following 24 h subjects will consume meals that will be selected by the Unit of Clinical Nutrition at Sourasky Medical Center nutritionist on the basis of their food diary and ALL urine excreted during this time should be collected in a designated urine container and returned to the Unit of Clinical Nutrition at Sourasky Medical Center for evaluation. The same protocol as in day 0 with a crossover oral treatment will be performed after 21 day washout period.
Dosing day will be designated "Day 0". Eligible subjects are randomly assigned to one of the study treatments according to the following regimens:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCC | Placebo comparator | Other: CCCCrystalline calcium carbonate (CCC) |
| ACC | Experimental | Other: ACCAmorphous calcium carbonate (ACC) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L
- BMI 18-29 (inclusive)
- Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects who provide written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Women who, on the basis of a food frequency questionnaire, have an estimated daily calcium intake >1100 mg through combined diet (both supplements and food).
- Women with vitamin D deficiency < 30 ng/ml
- Women with hypercalcemia, nephrolithiasis, inflammatory bowel disease, malabsorption, chronic diarrhea, use of antibiotics within the past month, Woman suffering from digestive, hepatic, renal, or inflammatory diseases.
- Women who take oral steroids, anticonvulsants, bisphosphonates, estrogen compounds, calcitonin, or teriparatide within the past 6 months.
- Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator (PI).
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 |
|---|---|---|
| CCC600 mg (2 capsules of 300 mg) for oral use of 480 mg CCC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca and 120 mg of inactive filler, sucrose. 1.5 mg of 42Ca labeled CaCl2 through IV injection | Other | CCC |
| ACC600 mg (2 capsules of 300 mg) for oral use containing 600 mg ACC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca 1.5 mg of 42Ca labeled CaCl2 through IV injection | Other | ACC |
Primary outcome
Mean change in fractional absorption of calcium from amorphous calcium carbonate (ACC) Vs. crystalline calcium carbonate (CCC).
Time frame: 1 year
Fractional absorption will be evaluated by measuring 42Ca and 44Ca levels in the urine over 24 hours (the ratio)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CCC and ACC in people with Postmenopause, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Apr 2011. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, Professor (009-972-3-6974807, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in fractional absorption of calcium from amorphous calcium carbonate (ACC) Vs. crystalline calcium carbonate (CCC). (time frame: 1 year). 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 19 Apr 2011.