A Study on the Impact of Calcium on Woman's Vascular Health
The Effect of Dietary Calcium Intake as Compared to Calcium Supplementation on Vascular Health and Bone Health in Postmenopausal Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3G 1A4
- Department of Internal Medicine; Montreal General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women aged 50 or more
- 2 years since last menstrual period
- Body Mass Index between 20 and 35 kg/m2
Exclusion Criteria:
- Atrial Fibrillation
- Coronary artery disease
- Myocardial infarction
- Stroke
- Transient ischaemic attack
- Peripheral vascular disease
- Sleep apnea
- Hypertension
- Hyperlipidemia
- Hyperparathyroidism
- Urinary tract lithiasis
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Short gut syndrome
- Celiac disease
- Diabetes
- Cancer (any other than basal cell cancer of the skin)
- Pre-eclampsia
- 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%)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Supplemental Calcium
|
750mg
450 mg
|
|
ACTIVE_COMPARATOR: Dietary Calcium
|
1200 mg
|
|
NO_INTERVENTION: Usual Diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vascular System
Time Frame: 12 months
|
Measured as changes in:
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodynamics
Time Frame: 12 Months
|
Measured as changes in: - Peripheral blood pressure |
12 Months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Biomarkers
Time Frame: 12 months
|
Measured as changes in:
|
12 months
|
|
Anthropomorphic measurements
Time Frame: 12 months
|
Measured as changes in bone health biomarkers.
|
12 months
|
|
Adverse Events
Time Frame: 12 months
|
Occurrence of cardiovascular, cerebrovascular and renal events as well as fractures and intolerance to interventions.
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Suzanne Morin, MD MSc, McGill University Hospital Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEN-11-231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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