Disorders of Phosphorus and Calcium MetabolismTSHPTHCANCT02035033
The Relationship Between Ca Intake , Blood Level of Ca, PTH, TSH, Vitamin D, and Urine Ca, P and Cardiac Calcium Scoring
An observational study of Disorders of Phosphorus and Calcium Metabolism, run by Carmel Medical Center.
Trial summary
Osteoporosis (op) is a disorder of bone characterized by reduced mineral density and bone mass. The first step in the prevention and treatment of Op is ensuring adequate intake of calcium and vitamin D . Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Disorders of Phosphorus and Calcium Metabolism
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Feb 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: participants how recent or planned cardiac CT in the Carmel hospital.
Who may be able to join
- Male and Female. Aged 50-80 years. Hebrew speakers -
Who cannot join
- Below age 50 years. Above age 80 years. Previous cardiac surgery . Inadequate cardiac CT study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Relationship Between Calcium and Cardiac Calcium Scoring
Osteoporosis (op) is a disorder of bone characterized by reduced mineral density and bone mass. The first step in the prevention and treatment of Op is ensuring adequate intake of calcium and vitamin D . While calcium supplementations clearly slow bone loss in both sexes,their effects on fracture risk are less certain. In contrast to the above a recent randomized, placebo controlled trial in 1471 postmenopausal women (mean age 74) reported in the BMJ (2 February 2008) found an increased rate of vascular events in healthy older women receiving calcium supplementation. The mechanism is not clear .we are trying to identify a possible correlation between calcium intake and calcium cardiac scoring .
Read the detailed description
BACKGROUND:
- Osteoporosis (op) is a disorder of bone characterized by reduced mineral density and bone mass. The first step in the prevention and treatment of Op is ensuring adequate intake of calcium and vitamin D . While calcium supplementations clearly slow bone loss in both sexes,(1,2) their effects on fracture risk are less certain.(3,4)
- Experimental data suggest that . vitamin D 25 affects cardiac muscle directly; controls PTH secretion, regulates the rennin-angiotensin - aldosterone system, and modulates the immune system.(5) Vitamin D deficiency has been associated with hypertension; several types of vascular disease and heart failure.
- Evidence suggests that high calcium intake might protect against vascular disease.
There is evidence that calcium intake might impact on serum lipid concentrations.(6) There is also evidence that calcium supplementation reduces blood pressure,(7) and that CV mortality is lower in hard water areas.(8)
In contrast to the above a recent randomized, placebo controlled trial in 1471 postmenopausal women (mean age 74) reported in the BMJ (2 February 2008) found an increased rate of vascular events in healthy older women receiving calcium supplementation.
Outcome measures were assesed over 5 years and included death, myocardial infarction, , stroke, transient ischaemic attack and development of angina pectoris.A composite end point of major adverse events (MACE= major advrse cardiac events) included myocardial infarction, stroke, or sudden death. MACE was also more common in the calcium group (101 events in 69 women v 54 events in 42 women, P=0.008). Adjudicated myocardial infarction was more common in the calcium group (24 events in 21 women v 10 events in 10 women, relative risk 2.12, 95% confidence interval 1.01 to 4.47).For stroke the relative risk was 1.37 (0.83 to 2.28) and the rate ratio was 1.45 (0.88 to 2.49). The authors concluded that calcium supplementation in healthy postmenopausal women is associated with upward trends in cardiovascular event rates and that this potentially detrimental effect should be balanced against the likely benefits of calcium on bone. (9) Possible mechanisms: The finding of an adverse trend in vascular events with calcium supplementation is not necessarily surprising, since calcium supplements acutely elevate serum calcium levels possibly accelerating vascular calcification, which is predictive of vascular event rates. Multiple observational studies have shown that cardiac event rate increases markedly over several years of follow-up with increasing levels of CAC(Coronary artery calcium) independently of conventional risk factors. CAC scoring has been advocated asa screening test for coronary disease risk in individuals at intermediate risk for coronary events
AIMS of current study: To define the relationship between calcium in the diet and supplementation to the level of TSH : PTH; vitamin D; creatinine in blood; calcium and Phosphor in blood and urine and the calcium score in the coronary blood vessels .
Methods:
Prospective study One center study includes Carmel hospital ;Line clinic and Zvolon clinic. Collaboration between the radiologic department in Carmel hospital and the endocrine department in Line and Zolon.
Includes 500 participants how recent or planned cardiac CT in the Carmel hospital.
The subject will sign an informed consent before the collection of blood tests for calcium, phosphor, creatinin, vitamin D, and PTH , TSH, urine tests for calcium if they don't have a recent tests(three month) in the OPHEQ .
Questionnaire. -
Inclusion criteria:
Recent or planned coronary artery calcium scoring performed at Carmel Hospital With or without simultaneously performed cardiac CT angiography.
Male and Female. Aged 50-80 years. Hebrew speakers
Exclusion criteria:
Below age 50 years. Above age 80 years. Previous cardiac surgery . Inadequate cardiac CT study
End point:
Correlation between calcium score and the level of VIT D,PTH;TSH in the blood Calcium phosphor in blood and urine and calcium in diet and supplementation.
Statistical analysis:
Standard statistical analysis techniques SPSS 14 (T TEST, ANOVA, Spearman\&Pearson correlation, will used in order to find the correlation between calcium score and blood levels of the above.
Bibliography :
- Randomized controlled trial of calcium supplementation in healthy, non osteoporotic, older men. Reid IR; Ames R; Mason B; Reid HE; Bacon CJ; Bolland MJ; Gamble GD; Grey A; Horne A Arch Intern Med. 2008 Nov 10;168(20):2276-82.
- Randomized controlled trial of calcium in healthy older women. Reid IR; Mason B; Horne A; Ames R; Reid HE; Bava U; Bolland MJ; Gamble GD Am J Med. 2006 Sep;119(9):777-85.
- Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis. Tang BM; Eslick GD; Nowson C; Smith C; Bensoussan A Lancet. 2007 Aug 25;370(9588):657-66.
- Reid ,I.R.,Bolland ,M.J\& Gery ,A Effect of calcium supplementation on hip fractures. Osteoporosis International 19 ,1119-1123.
- Rammos G,Tseke P,Ziakka S. vitamin D,the rennin-angiotensin system,and insulin resistance . Int Urol Nephrology.2008 ;40:419-26.
- Reid IR, Mason B, Horne A, Ames R, Clearwater J, Bava U, et al. Effects of calcium supplementation on serum lipid concentrations in normal older women: a randomized controlled trial. Am J Med 2002;112:343-
- Griffith LE, Guyatt GH, Cook RJ, Bucher HC, Cook DJ. The influence of dietary and nondietary calcium supplementation on blood pressure-an updated metaanalysis of randomized controlled trials. Am J Hypertens 1999;12:84
- Dawson EB, Frey MJ, Moore TD, McGanity WJ. Relationship of metal metabolism to vascular disease mortality rates in Texas. Am J Clin Nutr 1978;31:1188-97
- Mark J Bolland, research fellow1, P Alan Barber, senior lecturer1, Robert N Doughty, associate professor1, Barbara Mason, research officer1, Anne Horne, research fellow1, Ruth Ames, research officer1, Gregory D Gamble, research fellow1, Andrew Grey, associate professor1, Ian R Reid, professor1 Vascular events in healthy older women receiving calcium supplementation: randomized controlled trial BMJ 2008;336:262-266 (2 February), doi:10.1136/bmj.39440.525752.BE (published 15 January 2008 ontrolled trial.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| low calcium supplement | low calcium supplement | |
| Calcium intake 500-1000 mg per day | Calcium intake 500-1000 mg per day | |
| Calcium intake above 1000 mg per day | Calcium intake above 1000 mg per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of calcium intake for heart
Measured: 2 years frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Phosphorus and Calcium MetabolismStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nariman Saba Khazan, Carmel Medical Center
- Investigators
- Nathan Peled, Prof., Study chair, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035033
- Sponsor's protocol ID
- CMC-13-0003-CTIL
- Acronym
- TSHPTHCA
- Status last verified
- Jan 2014
- First submitted
- 9 Nov 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Calcium and Cardiac Calcium Scoring
- ClinicalTrials.gov ID
- NCT02035033
- Acronym / sponsor ID
- TSHPTHCA / CMC-13-0003-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 14 Jan 2014 (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.
Osteoporosis (op) is a disorder of bone characterized by reduced mineral density and bone mass. The first step in the prevention and treatment of Op is ensuring adequate intake of calcium and vitamin D . While calcium supplementations clearly slow bone loss in both sexes,their effects on fracture risk are less certain. In contrast to the above a recent randomized, placebo controlled trial in 1471 postmenopausal women (mean age 74) reported in the BMJ (2 February 2008) found an increased rate of vascular events in healthy older women receiving calcium supplementation. The mechanism is not clear .we are trying to identify a possible correlation between calcium intake and calcium cardiac scoring .
Detailed description
BACKGROUND:
- Osteoporosis (op) is a disorder of bone characterized by reduced mineral density and bone mass. The first step in the prevention and treatment of Op is ensuring adequate intake of calcium and vitamin D . While calcium supplementations clearly slow bone loss in both sexes,(1,2) their effects on fracture risk are less certain.(3,4)
- Experimental data suggest that . vitamin D 25 affects cardiac muscle directly; controls PTH secretion, regulates the rennin-angiotensin - aldosterone system, and modulates the immune system.(5) Vitamin D deficiency has been associated with hypertension; several types of vascular disease and heart failure.
- Evidence suggests that high calcium intake might protect against vascular disease.
There is evidence that calcium intake might impact on serum lipid concentrations.(6) There is also evidence that calcium supplementation reduces blood pressure,(7) and that CV mortality is lower in hard water areas.(8)
In contrast to the above a recent randomized, placebo controlled trial in 1471 postmenopausal women (mean age 74) reported in the BMJ (2 February 2008) found an increased rate of vascular events in healthy older women receiving calcium supplementation.
Outcome measures were assesed over 5 years and included death, myocardial infarction, , stroke, transient ischaemic attack and development of angina pectoris.A composite end point of major adverse events (MACE= major advrse cardiac events) included myocardial infarction, stroke, or sudden death. MACE was also more common in the calcium group (101 events in 69 women v 54 events in 42 women, P=0.008). Adjudicated myocardial infarction was more common in the calcium group (24 events in 21 women v 10 events in 10 women, relative risk 2.12, 95% confidence interval 1.01 to 4.47).For stroke the relative risk was 1.37 (0.83 to 2.28) and the rate ratio was 1.45 (0.88 to 2.49). The authors concluded that calcium supplementation in healthy postmenopausal women is associated with upward trends in cardiovascular event rates and that this potentially detrimental effect should be balanced against the likely benefits of calcium on bone. (9) Possible mechanisms: The finding of an adverse trend in vascular events with calcium supplementation is not necessarily surprising, since calcium supplements acutely elevate serum calcium levels possibly accelerating vascular calcification, which is predictive of vascular event rates. Multiple observational studies have shown that cardiac event rate increases markedly over several years of follow-up with increasing levels of CAC(Coronary artery calcium) independently of conventional risk factors. CAC scoring has been advocated asa screening test for coronary disease risk in individuals at intermediate risk for coronary events
AIMS of current study: To define the relationship between calcium in the diet and supplementation to the level of TSH : PTH; vitamin D; creatinine in blood; calcium and Phosphor in blood and urine and the calcium score in the coronary blood vessels .
Methods:
Prospective study One center study includes Carmel hospital ;Line clinic and Zvolon clinic. Collaboration between the radiologic department in Carmel hospital and the endocrine department in Line and Zolon.
Includes 500 participants how recent or planned cardiac CT in the Carmel hospital.
The subject will sign an informed consent before the collection of blood tests for calcium, phosphor, creatinin, vitamin D, and PTH , TSH, urine tests for calcium if they don't have a recent tests(three month) in the OPHEQ .
Questionnaire. -
Inclusion criteria:
Recent or planned coronary artery calcium scoring performed at Carmel Hospital With or without simultaneously performed cardiac CT angiography.
Male and Female. Aged 50-80 years. Hebrew speakers
Exclusion criteria:
Below age 50 years. Above age 80 years. Previous cardiac surgery . Inadequate cardiac CT study
End point:
Correlation between calcium score and the level of VIT D,PTH;TSH in the blood Calcium phosphor in blood and urine and calcium in diet and supplementation.
Statistical analysis:
Standard statistical analysis techniques SPSS 14 (T TEST, ANOVA, Spearman\&Pearson correlation, will used in order to find the correlation between calcium score and blood levels of the above.
Bibliography :
- Randomized controlled trial of calcium supplementation in healthy, non osteoporotic, older men. Reid IR; Ames R; Mason B; Reid HE; Bacon CJ; Bolland MJ; Gamble GD; Grey A; Horne A Arch Intern Med. 2008 Nov 10;168(20):2276-82.
- Randomized controlled trial of calcium in healthy older women. Reid IR; Mason B; Horne A; Ames R; Reid HE; Bava U; Bolland MJ; Gamble GD Am J Med. 2006 Sep;119(9):777-85.
- Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis. Tang BM; Eslick GD; Nowson C; Smith C; Bensoussan A Lancet. 2007 Aug 25;370(9588):657-66.
- Reid ,I.R.,Bolland ,M.J\& Gery ,A Effect of calcium supplementation on hip fractures. Osteoporosis International 19 ,1119-1123.
- Rammos G,Tseke P,Ziakka S. vitamin D,the rennin-angiotensin system,and insulin resistance . Int Urol Nephrology.2008 ;40:419-26.
- Reid IR, Mason B, Horne A, Ames R, Clearwater J, Bava U, et al. Effects of calcium supplementation on serum lipid concentrations in normal older women: a randomized controlled trial. Am J Med 2002;112:343-
- Griffith LE, Guyatt GH, Cook RJ, Bucher HC, Cook DJ. The influence of dietary and nondietary calcium supplementation on blood pressure-an updated metaanalysis of randomized controlled trials. Am J Hypertens 1999;12:84
- Dawson EB, Frey MJ, Moore TD, McGanity WJ. Relationship of metal metabolism to vascular disease mortality rates in Texas. Am J Clin Nutr 1978;31:1188-97
- Mark J Bolland, research fellow1, P Alan Barber, senior lecturer1, Robert N Doughty, associate professor1, Barbara Mason, research officer1, Anne Horne, research fellow1, Ruth Ames, research officer1, Gregory D Gamble, research fellow1, Andrew Grey, associate professor1, Ian R Reid, professor1 Vascular events in healthy older women receiving calcium supplementation: randomized controlled trial BMJ 2008;336:262-266 (2 February), doi:10.1136/bmj.39440.525752.BE (published 15 January 2008 ontrolled trial.
Study design
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low calcium supplement | – | –low calcium supplement |
| Calcium intake 500-1000 mg per day | – | –Calcium intake 500-1000 mg per day |
| Calcium intake above 1000 mg per day | – | –Calcium intake above 1000 mg per day |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participants how recent or planned cardiac CT in the Carmel hospital.
Key inclusion criteria (1 listed)
- Male and Female. Aged 50-80 years. Hebrew speakers -
Key exclusion criteria (1 listed)
- Below age 50 years. Above age 80 years. Previous cardiac surgery . Inadequate cardiac CT study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The safety of calcium intake for heart
Time frame: 2 years frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
Nathan Peled, Prof. study chair
Clalit Health Services
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Phosphorus and Calcium Metabolism, run by Carmel Medical Center.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nariman Saba Khazan, MD (972544727672, hazan@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of calcium intake for heart (time frame: 2 years frame). 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 14 Jan 2014.