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

NCT ID: NCT01731340

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2018-11-14

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.

Conditions

Cardiovascular Diseases; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Supplemental Calcium

• 750 mg Calcium Citrate per day
• 800 IU Vitamin D3 per day
• Low Dietary Calcium (450 mg per day)

Group Type: ACTIVE_COMPARATOR

Calcium Citrate

Intervention Type: DIETARY_SUPPLEMENT

750mg

Low Dietary Calcium

Intervention Type: OTHER

450 mg

Dietary Calcium

• 400 IU Vitamin D3 per day
• High Dietary Calcium (1200 mg per day)

Group Type: ACTIVE_COMPARATOR

High Dietary Calcium

Intervention Type: OTHER

1200 mg

Usual Diet

• 400 IU Vitamin D3 per day
• Unrestricted Dietary Calcium

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Calcium Citrate

750mg

Intervention Type: DIETARY_SUPPLEMENT

Low Dietary Calcium

450 mg

Intervention Type: OTHER

High Dietary Calcium

1200 mg

Intervention Type: OTHER

Eligibility Criteria

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%)

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Suzanne Morin

MD MSc FRCP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Morin, MD MSc

Role: PRINCIPAL_INVESTIGATOR

McGill University Hospital Center

Locations

Department of Internal Medicine; Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

GEN-11-231

Identifier Type: -

Identifier Source: org_study_id