Cardiovascular DiseasesPhase 4NCT01731340
A Study on the Impact of Calcium on Woman's Vascular Health
A Phase 4 study testing Calcium Citrate, Low Dietary Calcium and High Dietary Calcium in people with Cardiovascular Diseases and Osteoporosis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Osteoporosis
- What is being tested?
- Calcium Citrate, Low Dietary Calcium and High Dietary Calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to 14 Nov 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 50 or more
- 2 years since last menstrual period
- Body Mass Index between 20 and 35 kg/m2
Who cannot join
- Atrial Fibrillation
- Coronary artery disease
- Myocardial infarction
- Stroke
- Transient ischaemic attack
- Peripheral vascular disease
Show all 27Show fewer
- 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%)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Internal Medicine; Montreal General Hospital
Montreal, Quebec, H3G 1A4
About this study
Official title: 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.
Read the 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
- Being tested
- Calcium Citrate, Low Dietary Calcium, High Dietary Calcium
- Keywords
- Calcium Supplements, Dairy Foods, Cardiovascular Diseases, Osteoporosis, Postmenopause, Vitamin D, Micronutrients, Primary Prevention, Bone Health
- Medical subject headings
- Cardiovascular Diseases, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium CitrateDietary supplement
750mg
Low Dietary CalciumOther
450 mg
High Dietary CalciumOther
1200 mg
| Study group | Role | What they receive |
|---|---|---|
| Supplemental Calcium | Active comparator | * 750 mg Calcium Citrate per day
* 800 IU Vitamin D3 per day
* Low Dietary Calcium (450 mg per day) Receives: Dietary Supplement: Calcium Citrate; Other: Low Dietary Calcium |
| Dietary Calcium | Active comparator | * 400 IU Vitamin D3 per day
* High Dietary Calcium (1200 mg per day) Receives: Other: High Dietary Calcium |
| Usual Diet | No intervention | * 400 IU Vitamin D3 per day * Unrestricted Dietary Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular System
Measured as changes in:
- Arterial stiffness (carotid-femoral pulse wave velocity)
- Arterial wall thickness (carotid intima-media thickness)
Measured: 12 months
Secondary outcomes (1)
Hemodynamics
Measured as changes in:
- Peripheral blood pressure
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJun 2012
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Morin, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Suzanne Morin, MD MSc, Principal investigator, McGill University Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731340
- Sponsor's protocol ID
- GEN-11-231
- Status last verified
- Sep 2019
- First submitted
- 16 Nov 2012
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Calcium Intake as Compared to Calcium Supplementation on Vascular Health and Bone Health in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01731340
- Acronym / sponsor ID
- GEN-11-231
- Conditions
- Cardiovascular Diseases, Osteoporosis
- Keywords
- Calcium Supplements, Dairy Foods, Cardiovascular Diseases, Osteoporosis, Postmenopause, Vitamin D, Micronutrients, Primary Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supplemental Calcium | Active comparator | Dietary Supplement: Calcium Citrate, Other: Low Dietary Calcium* 750 mg Calcium Citrate per day * 800 IU Vitamin D3 per day * Low Dietary Calcium (450 mg per day) |
| Dietary Calcium | Active comparator | Other: High Dietary Calcium* 400 IU Vitamin D3 per day * High Dietary Calcium (1200 mg per day) |
| Usual Diet | No intervention | –* 400 IU Vitamin D3 per day * Unrestricted Dietary Calcium |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 50 or more
- 2 years since last menstrual period
- Body Mass Index between 20 and 35 kg/m2
Key exclusion criteria (27 listed)
- Atrial Fibrillation
- Coronary artery disease
- Myocardial infarction
- Stroke
- Transient ischaemic attack
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Citrate750mg | Dietary supplement | Supplemental Calcium |
| Low Dietary Calcium450 mg | Other | Supplemental Calcium |
| High Dietary Calcium1200 mg | Other | Dietary Calcium |
Primary outcome
Vascular System
Time frame: 12 months
Measured as changes in: * Arterial stiffness (carotid-femoral pulse wave velocity) * Arterial wall thickness (carotid intima-media thickness)
1 secondary outcome
Hemodynamics
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Morin, MD MSc principal investigator
McGill University Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium Citrate, Low Dietary Calcium and High Dietary Calcium in people with Cardiovascular Diseases and Osteoporosis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular System (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.