Is Calcium Obtained From Food Better for Vascular and Bone Health Than That Obtained From Supplements?
The purpose of this randomized clinical trial is to estimate the effect of dietary intake of calcium and vitamin D as compared to supplemental calcium and vitamin D on arterial stiffness and markers of vascular and bone health in postmenopausal women.
Dietary Supplement: Calcium Citrate
Dietary Supplement: Vitamin D3
Other: Dietary Calcium
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Effect of Dietary Calcium Intake as Compared to Calcium Supplementation on Vascular and Bone Health in Postmenopausal Women|
- Vascular Health [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Measured as changes in:
- arterial stiffness (carotid-femoral pulse wave velocity)
- arterial wall thickness (carotid intima-media thickness)
- arterial blood pressure
- vascular health biomarkers
- Bone Health [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Measured as changes in bone health biomarkers.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Calcium Supplement + Vitamin D Supplement
||Dietary Supplement: Calcium Citrate Dietary Supplement: Vitamin D3 Other: Dietary Calcium|
Active Comparator: Dietary Calcium + Vitamin D Supplement
||Dietary Supplement: Vitamin D3 Other: Dietary Calcium|
Active Comparator: Regular Diet + Vitamin D Supplement
||Dietary Supplement: Vitamin D3|
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 and vitamin D as compared to supplemental calcium and vitamin D 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 breakfast; (2) 450 mg of calcium from dietary sources, 3 tablets of 250 mg calcium supplement, and 1 capsule of 800 IU vitamin D supplement every day after breakfast; or (3) unrestricted calcium from dietary sources and 1 capsule of 400 IU vitamin D supplement everyday after breakfast. Participants have an equal chance of being assigned to any of these three groups.
Participants will also attend appointments at the Montreal General Hospital every 6-months where they will undergo anthropometric measurements, blood 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.
|Contact: Michelle Wall, MSc||514-934-1934 ext firstname.lastname@example.org|
|Department of Internal Medicine; Montreal General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Contact: Michelle Wall, MSc 514-934-1934 ext 45742 email@example.com|
|Principal Investigator: Suzanne Morin, MD MSc|
|Principal Investigator:||Suzanne Morin, MD MSc||McGill University Hospital Center|