Calcium Absorption in Postmenopausal Thai Women

NCT ID: NCT02291315

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Fractional Calcium Absorption

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

53 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prapaisri P. Sirichakwal, PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Human Metabolic Research Unit

Ithaca, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25809682 (View on PubMed)

Other Identifiers

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IRB #: MU 2007-145

Identifier Type: -

Identifier Source: org_study_id