Completed

NCT Number: NCT02291315

Calcium Absorption in Postmenopausal Thai 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.

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Key information

Conditions

Fractional Calcium Absorption

Age range

53 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Human Metabolic Research Unit

Ithaca, New York, 14853, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 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.

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

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

Ramathibodi Hospital

Registry information

Official study title

Calcium Bioavailability of Cassia Leaves in Post-Menopausal Women

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Nov 14, 2014
Registry last updated: Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.