ClinicalTrials.gg
Status unknownNCT02035033TSHPTHCAUpdated Jan 14, 2014

The Relationship Between Ca Intake , Blood Level of Ca, PTH, TSH, Vitamin D, and Urine Ca, P and Cardiac Calcium Scoring

An observational study in Disorders of Phosphorus and Calcium Metabolism, sponsored by Carmel Medical Center. Status unknown. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-01-14.

Sponsored by Carmel Medical Center · Observational

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
500
Ages
50 Years to 80 Years
Sex
All
01

Study 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 . 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.
02

Conditions studied

  • Disorders of Phosphorus and Calcium Metabolism
03

In context

Lead sponsor

Carmel Medical Center is the lead sponsor of 119 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

participants how recent or planned cardiac CT in the Carmel hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male and Female. Aged 50-80 years. Hebrew speakers -

Exclusion criteria

Exclusion Criteria:

- Below age 50 years. Above age 80 years. Previous cardiac surgery . Inadequate cardiac CT study

05

Study design

Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. The safety of calcium intake for heart

    Time frame: 2 years frame

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Dec 2015 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2013
First posted
Jan 14, 2014
Start
Jan 2014
Primary completionEst.
Dec 2015
CompletionEst.
Feb 2016
Last update
Jan 14, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02035033
Responsible party
Nariman Saba Khazan (Head of Endocrinology Department - Lin, Carmel Medical Center) — Principal investigator
First posted
Jan 14, 2014
Start date
Jan 2014
Primary completion
Dec 2015 (estimated)
Completion
Feb 2016 (estimated)
Last update
Jan 14, 2014

Study contacts

Nariman Saba Khazan, MD
Contact
hazan@clalit.org.il
972544727672
Nathan Peled, Prof.
study chair · Clalit Health Services

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion