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The Interaction Between Calcium and Vitamin D Intake | Clinical Trials | Clareo Health

COMPLETEDNA

The Interaction Between Calcium and Vitamin D Intake

NCT00762775•Winthrop University Hospital

Summary

We will study the relative importance of high calcium intake and vitamin D supplementation for calcium homeostasis, as determined by serum parathyroid hormone (PTH) and biochemical bone markers. We also intend to examine the interaction of vitamin D and calcium intake on calcium homeostasis. We hypothesize that optimal calcium supplementation and optimal vitamin D supplementation will lead to lower serum levels of PTH and markers of bone resorption compared with the placebo. We also theorize that when taken together, optimal calcium supplementation and optimal vitamin D intake will result in lower serum levels of PTH and bone markers compared with calcium or vitamin D taken alone.

Eligibility

Age

45 - 85 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy women aged 45 and above who have been menopausal at least 1 year (absence of menstrual period for a period of 12 months or more)

Exclusion Criteria

•Any chronic medical illness including uncontrolled diabetes mellitus, recent history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, obesity (BMI\>35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.
•Subjects with osteoporosis of the hip (total hip T-score equal or less than -2.5) or taking medications for osteoporosis such as bisphosphonates will be excluded.
•Pregnancy.
•Use of medication that influences bone metabolism (i.e. anticonvulsant medications, chronic use of steroids and high dose diuretics).
•Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator.
•Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis will also be excluded.
•Participation in another investigational trial in the past 30 days prior to the screening evaluation.
•Unexplained weight loss of \>15% during the previous year or history of anorexia nervosa.
•Medications that interfere with vitamin D metabolism.
•Patients with a habitual dietary calcium intake that exceeds 800 mg/day.
+3 more criteria

Locations (1)

Winthrop University Hospital

Mineola, New York, United States

Key Dates

Start Date

November 1, 2008

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

December 11, 2014

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

Calcium and vitamin D supplementation

DIETARY_SUPPLEMENT

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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The Interaction Between Calcium and Vitamin D Intake

Inclusion Criteria

Exclusion Criteria

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