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

Phase 4

Completed

• Conditions: Cardiovascular Diseases; Osteoporosis
• Interventions: Dietary Supplement: Calcium Citrate; Other: High Dietary Calcium; Other: Low Dietary Calcium

• Registration Number: NCT01731340
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

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 until 26 participants have been assigned to group (3). At this time participants will continue to be assigned by chance to either of the two remaining groups only.

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-21
• Primary Completion: 2018-11-14
• Study Completion: 2018-11-14
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

Inclusion Criteria

• Women aged 50 or more
• 2 years since last menstrual period
• Body Mass Index between 20 and 35 kg/m2

Exclusion Criteria

• 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
• Celiac disease
• Diabetes
• Cancer (any other than basal cell cancer of the skin)
• 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 oral glucocorticoids or HRT (excluding vaginal preparations) in the last 2 years
• Use of anti-osteoporosis medications (bisphosphonates, selective estrogen-receptor modulators, denosumab, teriparatide, or calcitonin) in the last 3 years or anti-osteoporosis therapy which ended more than 3 years ago and whose duration was ≥ 5 years, or a fracture of the spine, shoulder, or hip was sustained while therapy
• 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%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplemental Calcium	Calcium Citrate	* 750 mg Calcium Citrate per day * 800 IU Vitamin D3 per day * Low Dietary Calcium (450 mg per day)
Supplemental Calcium	Low Dietary Calcium	* 750 mg Calcium Citrate per day * 800 IU Vitamin D3 per day * Low Dietary Calcium (450 mg per day)
Dietary Calcium	High Dietary Calcium	* 400 IU Vitamin D3 per day * High Dietary Calcium (1200 mg per day)

Primary Outcome Measures

Name	Time	Method
Vascular System	12 months	Measured as changes in: * Arterial stiffness (carotid-femoral pulse wave velocity); * Arterial wall thickness (carotid intima-media thickness)

Secondary Outcome Measures

Name	Time	Method
Hemodynamics	12 Months	Measured as changes in: - Peripheral blood pressure

Trial Locations

Locations (1)

Department of Internal Medicine; Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada