Fractional Calcium AbsorptionNCT02291315
Calcium Absorption in Postmenopausal Thai Women
An observational study of Fractional Calcium Absorption, run by Cornell University at 1 site in United States.
Trial summary
Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis. However, postmenopausal Thai women consume diets which are habitually low in calcium due to lactose intolerance and dietary patterns which typically do not include milk-based products. Read more about this study
- Who is it for?
- Ages 53 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fractional Calcium Absorption
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Sep 2007
- Phase
- Observational
- 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 53 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Post-menopausal Thai women
Who may be able to join
- Healthy
- At least 3 years postmenopausal
Who cannot join
- Diagnosed gastrointestinal or metabolic diseases known to interfere with calcium absorption and metabolism
- Women taking medications (including thiazide diuretics, hormonal replacement therapy, etc.) within two months prior to the study
- Women taking dietary supplements within two months prior to the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Metabolic Research Unit
Ithaca, New York, 14853
About this study
Official title: Calcium Bioavailability of Cassia Leaves in Post-Menopausal Women
Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis. However, postmenopausal Thai women consume diets which are habitually low in calcium due to lactose intolerance and dietary patterns which typically do not include milk-based products. The primary goal of this study is to measure the fractional calcium absorption from milk and a commonly ingested green leafy vegetable (cassia) in postmenopausal Thai women with habitually low calcium intakes. The secondary objective is to determine associations between calcium absorption and biomarkers which impact vitamin D status and bone metabolism.
Read the detailed description
Postmenopausal Thai women (n=22) will be recruited from the community surrounding Bangkok and Nakhon Pathon, Thailand. They will be invited to participate in an isotope study comparing the fractional calcium absorption from milk and cassia. Upon arrival, a fasting blood sample will be drawn on the morning of the absorption study to analyze serum markers of vitamin D and bone metabolism (25-hydroxy vitamin D [25OHD], parathyroid hormone [PTH], and beta-crossLaps) and to determine their impact on calcium absorption. Following this blood draw, women will receive a stable calcium isotope (42Ca) intravenously. Then for breakfast and lunch respectively, the women will be randomly assigned to orally ingest a stable calcium isotope from either the milk (44Ca) or cassia (43Ca) test meals. On day two, women will receive a breakfast, snack, and lunch meal. Urine samples will be collected over the entire 28 hour period and the 24-hr urine collection will be used to measure urinary calcium concentration and to calculate fractional calcium absorption.
- Conditions
- Fractional Calcium Absorption
- Keywords
- Triple Stable Isotope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Test meal ingestion | On the morning of the absorption study, fasted women received 2 mg of 42Ca intravenously (in 5 ml of isotonic saline) over 5 minutes before being randomly assigned to receive either the milk or cassia meal first for breakfast and the milk or cassia meal second for lunch. The milk meal consisted of approximately 100 mg of fresh ultrahigh temperature (UHT) milk to which 2 mg of 44Ca was added and allowed to equilibrate for 12 h prior to ingestion and the cassia meal consisted of 142 g of cooked cassia to which 1 mg of 43Ca was extrinsically added. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional calcium absorption
Urine samples will be collected over s 28 hour period post-dosing with collection ending 24 hours after the ingestion of the second test meal.
Measured: 24 hours after the ingestion of the second test meal
Secondary outcomes (3)
The concentration of 25-hydroxy vitamin D (25OHD) in serum
A fasting 10 mL blood sample will be collected upon entry into the study and used for determining the concentration of 25OHD in serum.
Measured: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
The concentration of parathyroid hormone (PTH) in serum
A fasting 10 mL blood sample will be collected upon entry into the study and used for determining the concentration of PTH in serum.
Measured: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
The concentration of beta-crossLaps in serum
A fasting 10 mL blood sample will be collected upon entry into the study and used for determining the concentration of beta-crossLaps in serum.
Measured: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJul 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fractional Calcium AbsorptionStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital
- Responsible party
- Sponsor
- Investigators
- Prapaisri P. Sirichakwal, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291315
- Sponsor's protocol ID
- IRB #: MU 2007-145
- Status last verified
- Nov 2014
- First submitted
- 10 Nov 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sirichakwal PP, Kamchansuppasin A, Akoh CC, Kriengsinyos W, Charoenkiatkul S, O'Brien KO. Vitamin D Status Is Positively Associated with Calcium Absorption among Postmenopausal Thai Women with Low Calcium Intakes. J Nutr. 2015 May;145(5):990-5. doi: 10.3945/jn.114.207290. Epub 2015 Mar 25.
PubMed 25809682
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Bioavailability of Cassia Leaves in Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT02291315
- Acronym / sponsor ID
- IRB #: MU 2007-145
- Conditions
- Fractional Calcium Absorption
- Keywords
- Triple Stable Isotope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital
- Study start
- Jul 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 14 Nov 2014 (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.
Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis. However, postmenopausal Thai women consume diets which are habitually low in calcium due to lactose intolerance and dietary patterns which typically do not include milk-based products. The primary goal of this study is to measure the fractional calcium absorption from milk and a commonly ingested green leafy vegetable (cassia) in postmenopausal Thai women with habitually low calcium intakes. The secondary objective is to determine associations between calcium absorption and biomarkers which impact vitamin D status and bone metabolism.
Detailed description
Postmenopausal Thai women (n=22) will be recruited from the community surrounding Bangkok and Nakhon Pathon, Thailand. They will be invited to participate in an isotope study comparing the fractional calcium absorption from milk and cassia. Upon arrival, a fasting blood sample will be drawn on the morning of the absorption study to analyze serum markers of vitamin D and bone metabolism (25-hydroxy vitamin D [25OHD], parathyroid hormone [PTH], and beta-crossLaps) and to determine their impact on calcium absorption. Following this blood draw, women will receive a stable calcium isotope (42Ca) intravenously. Then for breakfast and lunch respectively, the women will be randomly assigned to orally ingest a stable calcium isotope from either the milk (44Ca) or cassia (43Ca) test meals. On day two, women will receive a breakfast, snack, and lunch meal. Urine samples will be collected over the entire 28 hour period and the 24-hr urine collection will be used to measure urinary calcium concentration and to calculate fractional calcium absorption.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test meal ingestion | – | –On the morning of the absorption study, fasted women received 2 mg of 42Ca intravenously (in 5 ml of isotonic saline) over 5 minutes before being randomly assigned to receive either the milk or cassia meal first for breakfast and the milk or cassia meal second for lunch. The milk meal consisted of approximately 100 mg of fresh ultrahigh temperature (UHT) milk to which 2 mg of 44Ca was added and allowed to equilibrate for 12 h prior to ingestion and the cassia meal consisted of 142 g of cooked cassia to which 1 mg of 43Ca was extrinsically added. |
Who may qualify
- Ages
- 53 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Post-menopausal Thai women
Key inclusion criteria (2 listed)
- Healthy
- At least 3 years postmenopausal
Key exclusion criteria (3 listed)
- Diagnosed gastrointestinal or metabolic diseases known to interfere with calcium absorption and metabolism
- Women taking medications (including thiazide diuretics, hormonal replacement therapy, etc.) within two months prior to the study
- Women taking dietary supplements within two months prior to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fractional calcium absorption
Time frame: 24 hours after the ingestion of the second test meal
Urine samples will be collected over s 28 hour period post-dosing with collection ending 24 hours after the ingestion of the second test meal.
3 secondary outcomes
The concentration of 25-hydroxy vitamin D (25OHD) in serum
Time frame: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
The concentration of parathyroid hormone (PTH) in serum
Time frame: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
The concentration of beta-crossLaps in serum
Time frame: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
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 14 Nov 2014.
- Derived from this study: PubMed 25809682Sirichakwal PP, Kamchansuppasin A, Akoh CC, Kriengsinyos W, Charoenkiatkul S, O'Brien KO. Vitamin D Status Is Positively Associated with Calcium Absorption among Postmenopausal Thai Women with Low Calcium Intakes. J Nutr. 2015 May;145(5):990-5. doi: 10.3945/jn.114.207290. Epub 2015 Mar 25.
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.
Prapaisri P. Sirichakwal, PhD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractional Calcium Absorption, run by Cornell University at 1 site in United States.
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 2 inclusion and 3 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 14 Nov 2014. 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 United States. 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?
Fractional calcium absorption (time frame: 24 hours after the ingestion of the second test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291315, which also lists 1 linked publication.
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 14 Nov 2014.