Is Calcium Obtained From Food Better for Vascular and Bone Health Than That Obtained From Supplements?
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases Osteoporosis |
Dietary Supplement: Calcium Citrate Dietary Supplement: Vitamin D3 Other: Dietary Calcium |
Phase 4 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 180 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
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 |
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 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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women aged 55 or more;
- 3 years since last menstrual period
- Body Mass Index between 20 and 30 kg/m2
Exclusion Criteria:
- Atrial Fibrillation
- Documented atherosclerosis
- High 10-year absolute risk of fracture (FRAX without BMD > 20%)
- Hypertension
- Hyperparathyroidism
- Urinary Tract Lithiasis
- Rheumatoid Arthritis
- Diabetes
- History of gestational diabetes, hypertension, or pre-eclampsia
- Smoked in the last 5 years
- Use of bone active agents (oral glucocorticoids, bisphosphonates, Selective estrogen-receptor modulators, denosumab, teriparatide, calcitonin, HRT [excluding vaginal preparations])in the last 3 years
- Use of calcium and vitamin D supplements (including multivitamins and calcium-containing antacids) in the last 2 months
Contacts and Locations| Contact: Michelle Wall, MSc | 514-934-1934 ext 45742 | michelle.wall@mail.mcgill.ca |
| Canada, Quebec | |
| Department of Internal Medicine; Montreal General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Contact: Michelle Wall, MSc 514-934-1934 ext 45742 michelle.wall@mail.mcgill.ca | |
| Principal Investigator: Suzanne Morin, MD MSc | |
| Principal Investigator: | Suzanne Morin, MD MSc | McGill University Hospital Center |
More Information
No publications provided
| Responsible Party: | Suzanne Morin, MD MSc FRCP, McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT01731340 History of Changes |
| Other Study ID Numbers: | GEN-11-231 |
| Study First Received: | November 16, 2012 |
| Last Updated: | February 22, 2013 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by McGill University Health Center:
|
Calcium Supplements Dairy Foods Cardiovascular Diseases Osteoporosis Postmenopause |
Vitamin D Micronutrients Primary Prevention Bone Health |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Calcium, Dietary Cholecalciferol Vitamin D |
Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013