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

November 16, 2012
May 9, 2014
June 2012
June 2016   (final data collection date for primary outcome measure)
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)
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
Complete list of historical versions of study NCT01731340 on ClinicalTrials.gov Archive Site
Hemodynamics [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Measured as changes in:

- Peripheral blood pressure

Bone Health [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Measured as changes in bone health biomarkers.
  • 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.
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Osteoporosis
  • Dietary Supplement: Calcium Citrate
    750mg
  • Other: Low Dietary Calcium
    450 mg
  • Other: High Dietary Calcium
    1200 mg
  • Active Comparator: Supplemental Calcium
    • 750 mg Calcium Citrate per day
    • 800 IU Vitamin D3 per day
    • Low Dietary Calcium (450 mg per day)
    Interventions:
    • Dietary Supplement: Calcium Citrate
    • Other: Low Dietary Calcium
  • Active Comparator: Dietary Calcium
    • 400 IU Vitamin D3 per day
    • High Dietary Calcium (1200 mg per day)
    Intervention: Other: High Dietary Calcium
  • No Intervention: Usual Diet
    • 400 IU Vitamin D3 per day
    • Unrestricted Dietary Calcium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
June 2016
June 2016   (final data collection date for primary outcome measure)

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%)
Female
50 Years and older
Yes
Contact: Michelle Wall, MSc 514-934-1934 ext 45742 michelle.wall@mail.mcgill.ca
Canada
 
NCT01731340
GEN-11-231
No
Suzanne Morin, McGill University Health Center
McGill University Health Center
Not Provided
Principal Investigator: Suzanne Morin, MD MSc McGill University Hospital Center
McGill University Health Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP