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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Nariman Saba Khazan, MD contact

972544727672

hazan@clalit.org.il

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:

  1. 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)
  2. 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.
  3. 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 :

  1. 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.
  2. 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.
  3. 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.
  4. Reid ,I.R.,Bolland ,M.J\& Gery ,A Effect of calcium supplementation on hip fractures. Osteoporosis International 19 ,1119-1123.
  5. Rammos G,Tseke P,Ziakka S. vitamin D,the rennin-angiotensin system,and insulin resistance . Int Urol Nephrology.2008 ;40:419-26.
  6. 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-
  7. 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
  8. 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
  9. 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 groups in NCT02035033
Study groupRoleWhat they receive
low calcium supplementlow calcium supplement
Calcium intake 500-1000 mg per dayCalcium intake 500-1000 mg per day
Calcium intake above 1000 mg per dayCalcium intake above 1000 mg per day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted14 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionFeb 2016 (estimated)

Resources

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
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

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.

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