Calcium Absorption in Postmenopausal Thai Women

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • New York
    • Ithaca, New York, United States, 14853
      • Human Metabolic Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Post-menopausal Thai women

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours after the ingestion of the second test meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: Mahidol University, Ramathibodi Hospital
• Investigators: Principal Investigator: Prapaisri P. Sirichakwal, PhD, Mahidol University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Triple Stable Isotope
• Other Study ID Numbers: IRB #: MU 2007-145