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 Citrate
Other: Low Dietary Calcium
Other: High Dietary Calcium
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Full eligibility criteria for NCT01731340
Ages eligible for Study
50 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Women aged 50 or more
3 years since last menstrual period
Body Mass Index between 20 and 35 kg/m2
Coronary artery disease
Transient ischaemic attack
Peripheral vascular disease
Urinary tract lithiasis
Short gut syndrome
Cancer (any other than basal cell cancer of the skin)
Smoked in the last 5 years
Cocaine use in the last year
Consumption of more than 9 alcoholic drinks per week
Chronic NSAID use
Use of oral glucocorticoids or HRT (excluding vaginal preparations) in the last 2 years
Use of anti-osteoporosis medications (bisphosphonates, selective estrogen-receptor modulators, denosumab, teriparatide, or calcitonin) in the last 3 years or anti-osteoporosis therapy which ended more than 3 years ago and whose duration was ≥ 5 years, or a fracture of the spine, shoulder, or hip was sustained while therapy
Use of calcium and vitamin D supplements (including multivitamins and calcium-containing antacids) in the last 2 months
High 10-year probability of major osteoporotic fracture (FRAX without BMD > 20%)
All locations for NCT01731340
Department of Internal Medicine; Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
View full eligibility
Tris trial is registered with FDA with number: NCT01731340. The sponsor of the trial is McGill University Health Center and it is looking for 123 volunteers for the current phase.
Official trial title: The Effect of Dietary Calcium Intake as Compared to Calcium Supplementation on Vascular Health and Bone Health in Postmenopausal Women
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