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
1 other identifier
interventional
123
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 cardiovascular-diseases
Started Jun 2012
Longer than P75 for phase_4 cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 16, 2012
CompletedFirst Posted
Study publicly available on registry
November 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2018
CompletedSeptember 18, 2019
September 1, 2019
6.5 years
November 16, 2012
September 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vascular System
Measured as changes in: * Arterial stiffness (carotid-femoral pulse wave velocity) * Arterial wall thickness (carotid intima-media thickness)
12 months
Secondary Outcomes (1)
Hemodynamics
12 Months
Other Outcomes (3)
Blood Biomarkers
12 months
Anthropomorphic measurements
12 months
Adverse Events
12 months
Study Arms (3)
Supplemental Calcium
ACTIVE COMPARATOR* 750 mg Calcium Citrate per day * 800 IU Vitamin D3 per day * Low Dietary Calcium (450 mg per day)
Dietary Calcium
ACTIVE COMPARATOR* 400 IU Vitamin D3 per day * High Dietary Calcium (1200 mg per day)
Usual Diet
NO INTERVENTION* 400 IU Vitamin D3 per day * Unrestricted Dietary Calcium
Interventions
Eligibility Criteria
You may qualify if:
- Women aged 50 or more
- years since last menstrual period
- Body Mass Index between 20 and 35 kg/m2
You may not qualify if:
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine; Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Morin, MD MSc
McGill University Hospital Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD MSc FRCP
Study Record Dates
First Submitted
November 16, 2012
First Posted
November 21, 2012
Study Start
June 1, 2012
Primary Completion
November 14, 2018
Study Completion
November 14, 2018
Last Updated
September 18, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share