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Calcium Absorption in Postmenopausal Thai Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291315
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Collaborator:
Mahidol University, Ramathibodi Hospital
Information provided by (Responsible Party):
Cornell University

Brief 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. 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.

Condition or disease
Fractional Calcium Absorption

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.

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Calcium Bioavailability of Cassia Leaves in Post-Menopausal Women
Study Start Date : July 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    A fasting 10 mL blood sample will be collected upon entry into the study and used for determining the concentration of 25OHD in serum.

  2. 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. ]
    A fasting 10 mL blood sample will be collected upon entry into the study and used for determining the concentration of PTH in serum.

  3. 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. ]
    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.



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Ages Eligible for Study:   53 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Post-menopausal Thai women
Criteria

Inclusion Criteria:

  • Healthy
  • At least 3 years postmenopausal

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291315


Locations
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United States, New York
Human Metabolic Research Unit
Ithaca, New York, United States, 14853
Sponsors and Collaborators
Cornell University
Mahidol University, Ramathibodi Hospital
Investigators
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Principal Investigator: Prapaisri P. Sirichakwal, PhD Mahidol University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT02291315    
Other Study ID Numbers: IRB #: MU 2007-145
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Cornell University:
Triple Stable Isotope