A Study on the Impact of Calcium on Woman's Vascular Health

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Suzanne Morin, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01731340
First received: November 16, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Osteoporosis
Dietary Supplement: Calcium Citrate
Other: Low Dietary Calcium
Other: High 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 Health and Bone Health in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Vascular System [ 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)


Secondary Outcome Measures:
  • Hemodynamics [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    Measured as changes in:

    - Peripheral blood pressure



Other Outcome Measures:
  • Blood Biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Measured as changes in:

    • Vascular health biomarkers
    • Bone health biomarkers

  • Anthropomorphic measurements [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Measured as changes in bone health biomarkers.

    • Body mass index
    • Waist circumference
    • Body fat %

  • Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Occurrence of cardiovascular, cerebrovascular and renal events as well as fractures and intolerance to interventions.


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: Supplemental Calcium
  • 750 mg Calcium Citrate per day
  • 800 IU Vitamin D3 per day
  • Low Dietary Calcium (450 mg per day)
Dietary Supplement: Calcium Citrate
750mg
Other: Low Dietary Calcium
450 mg
Active Comparator: Dietary Calcium
  • 400 IU Vitamin D3 per day
  • High Dietary Calcium (1200 mg per day)
Other: High Dietary Calcium
1200 mg
No Intervention: Usual Diet
  • 400 IU Vitamin D3 per day
  • Unrestricted Dietary Calcium

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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  • Coronary artery disease
  • Myocardial infarction
  • Stroke
  • Transient ischaemic attack
  • Peripheral vascular disease
  • Hypertension
  • Hyperlipidemia
  • Hyperparathyroidism
  • Urinary tract lithiasis
  • Rheumatoid arthritis
  • Crohn's disease
  • Ulcerative colitis
  • Short gut syndrome
  • Celiac disease
  • Diabetes
  • History of gestational diabetes, hypertension, or 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 bone active agents (oral glucocorticoids, HRT [excluding vaginal preparations])in the last 3 years
  • Any use of anti-osteoporosis medication (bisphosphonates, Selective estrogen-receptor modulators, denosumab, teriparatide, calcitonin)
  • 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%)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731340

Contacts
Contact: Michelle Wall, MSc 514-934-1934 ext 45742 michelle.wall@mail.mcgill.ca

Locations
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         
Sponsors and Collaborators
McGill University Health Center
Investigators
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: May 9, 2014
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
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014