Clinical trial NCT02291315: Calcium Absorption in Postmenopausal Thai Women
Official title: Calcium Bioavailability of Cassia Leaves in Post-Menopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractional Calcium Absorption
Keywords: Triple Stable Isotope
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Mahidol University, Ramathibodi Hospital
First posted: 2014-11-14
Enrollment: 22
Sex: FEMALE
Minimum age (years): 53
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post-menopausal Thai women

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.

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.

Eligibility 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

Primary outcomes:
measure: Fractional calcium absorption
timeFrame: 24 hours after the ingestion of the second test meal
Secondary outcomes:
measure: The concentration of 25-hydroxy vitamin D (25OHD) in serum
timeFrame: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
measure: The concentration of parathyroid hormone (PTH) in serum
timeFrame: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
measure: The concentration of beta-crossLaps in serum
timeFrame: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Human Metabolic Research Unit
state: New York
Study officials:
affiliation: Mahidol University
name: Prapaisri P. Sirichakwal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.