Status:
COMPLETED
The Interaction Between Calcium and Vitamin D Intake
Lead Sponsor:
Winthrop University Hospital
Conditions:
Osteoporosis
Eligibility:
FEMALE
45-85 years
Phase:
NA
Brief 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 al...
Eligibility Criteria
Inclusion
- 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
- 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.
- Smokers greater than 1 pack per day will be excluded.
- Patients reporting alcohol intake greater than 2 drinks daily.
- Serum 25-hydroxyvitamin D level \> 75 nmol/L.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00762775
Start Date
November 1 2008
End Date
June 1 2011
Last Update
December 11 2014
Active Locations (1)
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1
Winthrop University Hospital
Mineola, New York, United States, 11501