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
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 .
BACKGROUND:
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.
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.
Carmel Medical Center is the lead sponsor of 119 studies on the registry; 7 are open to participants now.
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participants how recent or planned cardiac CT in the Carmel hospital.
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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
low calcium supplement
Calcium intake 500-1000 mg per day
Calcium intake above 1000 mg per day
The safety of calcium intake for heart
Time frame: 2 years frame
No study locations are listed for this record.
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.
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This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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