A Phase 4 interventional study of Calcium Citrate and Low Dietary Calcium in Cardiovascular Diseases and Osteoporosis, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Open to female participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-18.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 4, Interventional, and Prevention
The overarching aim of this randomized clinical trial is to estimate the effect of dietary intake of calcium as compared to supplemental calcium on the vascular system and markers of vascular and bone health in postmenopausal women.
Calcium and vitamin D are essential nutrients for optimal bone health throughout life. Research has shown that postmenopausal women who consume appropriate amounts of these nutrients have better bone strength and fewer fractures than those who don't. However, researchers have recently questioned the safety of calcium and vitamin D obtained through supplements as they might increase the risk of cardiovascular events such as heart attacks and strokes.
The investigators propose to estimate the effect of dietary intake of calcium as compared to supplemental calcium on vascular and bone health in postmenopausal women.
Eligible participants will be assigned by chance (like a coin toss) to one of three groups: (1) 1200 mg of calcium from dietary sources and 1 capsule of 400 IU vitamin D supplement everyday after the first meal of the day; (2) 450 mg of calcium from dietary sources, 2 tablets of 250 mg calcium citrate supplement and 1 capsule of 800 IU vitamin D supplement everyday after the first meal of the day and 1 tablet of 250 mg calcium citrate supplement after the evening meal or snack; or (3) unrestricted calcium from dietary sources and 1 capsule of 400 IU vitamin D supplement everyday after the first meal of the day. Participants have an equal chance of being assigned to any of these three groups until 26 participants have been assigned to group (3). At this time participants will continue to be assigned by chance to either of the two remaining groups only.
Participants will also attend appointments at the Montreal General Hospital every 6-months where they will undergo anthropometric measurements, blood tests, urine tests, non-invasive ultrasounds to measure arterial stiffness and questionnaires. The questionnaires ask about health; lifestyle habits such as physical exercise, diet, and smoking; use of medications and dietary supplements; family history of illness, and past medical diagnoses. Participants will also receive monthly phone calls from study staff to monitor for adverse events and adherence.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 123 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* 750 mg Calcium Citrate per day * 800 IU Vitamin D3 per day * Low Dietary Calcium (450 mg per day)
Dietary Supplement: Calcium Citrate · Other: Low Dietary Calcium
* 400 IU Vitamin D3 per day * High Dietary Calcium (1200 mg per day)
Other: High Dietary Calcium
* 400 IU Vitamin D3 per day * Unrestricted Dietary Calcium
750mg
450 mg
1200 mg
Vascular System
Measured as changes in: * Arterial stiffness (carotid-femoral pulse wave velocity) * Arterial wall thickness (carotid intima-media thickness)
Time frame: 12 months
Hemodynamics
Measured as changes in: - Peripheral blood pressure
Time frame: 12 Months
Blood Biomarkers
Measured as changes in: * Vascular health biomarkers * Bone health biomarkers
Time frame: 12 months
Anthropomorphic measurements
Measured as changes in bone health biomarkers. * Body mass index * Waist circumference * Body fat %
Time frame: 12 months
Adverse Events
Occurrence of cardiovascular, cerebrovascular and renal events as well as fractures and intolerance to interventions.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre