An observational study in Fractional Calcium Absorption, sponsored by Cornell University. Completed at 1 site in United States. Open to female participants aged 53 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-14.
Sponsored by Cornell University · Observational
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.
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.
Cornell University is the lead sponsor of 96 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Post-menopausal Thai women
Exclusion Criteria:
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.
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.
Time frame: 24 hours after the ingestion of the second test meal
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.
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
A fasting 10 mL blood sample will be collected upon entry into the study and used for determining the concentration of 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
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.
Time frame: Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cornell University