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Trial record 15 of 108 for:    CALCIUM CATION

Hypocalcemia in Infants and Children

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ClinicalTrials.gov Identifier: NCT03685877
Recruitment Status : Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Asmaa Mohammed Fathy Farghali, Assiut University

Brief Summary:

Hypocalcemia is defined as reduction in the level of the ionized calcium in the blood to less than 0.95 mmole/ litre.

In some cases it is associated with symptoms such as neuromuscular impairment in the form of convulsions ,carpopedal spasm,parathesia ,laryngiospasm ,stridor……etc .Calcium circulates in blood stream in three fractions :protein bound to calcium,primarly to albumen(40%) and in 50% of the cases calcium is present in the ionized state which is physiologically active (Dias ,c et a l, 2013) . Symptomatizing hypocalcemia may occur in cases of vitamin D deficiency rickets (nutritional deficiency in infants less than two years ) .It may also occur in vitamin D resistant rickets e.g renal rickets because of failure of the kidney to synthesize 1-OH cholecalciferol of the 1-25 di-OH cholecalciferol (the active form of vitamin D).


Condition or disease
Hypocalcemia

Detailed Description:

Hypocalcemia is defined as reduction in the level of the ionized calcium in the blood to less than 0.95 mmole/ litre.

In some cases it is associated with symptoms such as neuromuscular impairment in the form of convulsions ,carpopedal spasm,parathesia ,laryngiospasm ,stridor……etc .Calcium circulates in blood stream in three fractions :protein bound to calcium,primarly to albumen(40%) and in 50% of the cases calcium is present in the ionized state which is physiologically active (Dias ,c et a l, 2013) . Symptomatizing hypocalcemia may occur in cases of vitamin D deficiency rickets (nutritional deficiency in infants less than two years ) .It may also occur in vitamin D resistant rickets e.g renal rickets because of failure of the kidney to synthesize 1-OH cholecalciferol of the 1-25 di-OH cholecalciferol (the active form of vitamin D). In some cases the liver fails to synthesize the 25-OH group of the active 1-25 di hydroxy cholecalciferol . In cases of malabsorption hypocalcemia may occur because of lack of absorption of both calcium and vitamin D from the gastrointestinal tract.

Symptomatizing Ionized hypocalcemia has been reported as an early event associated with organ dysfunction in children admitted to intensive care unit. This suggests that hypocalcemia may occur in association with other causes than those mentioned above. It has been reported in cases with sepsis, shock and in association with the use of anticonvulsants. It may occur in cardiac arrythmia and tetany (Khadilkar,V & Khadilkar,V,2017).

Regulation of calcium haemostasis is done by two principle hormones: vitamin D and parathyroid hormone.

These hormones act on three target organs: the intestine, the kidney and bones. In cases of advanced vitamin D deficiency rickets and in cases of vitamin D resistant rickets compensatory hyperparathyroidism may occur.( Basatemur & Sutcliffe,2015) Research question: to find out the causes and differential diagnosis of syptomatizing hypocalcemia in infants and children admitted to Assiut University Children Hospital using the available datafrom the literature.

The current strategy for dealing with this problem will be described using an algorithm covering the various clinical presentations and investigations to reach the final diagnosis guided by( Fukomoto,S et al,2008 , Pacaud,D & Dawrant ,J,2007 as well as Kelly,A & Levine,M,2013)


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Profile of Hypocalcemia in Infants and Children Admitted to Assiut University Children Hospital
Estimated Study Start Date : March 30, 2019
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : April 1, 2020



Primary Outcome Measures :
  1. hypocalcemia in infants and children [ Time Frame: 1YEAR ]
    Good management of all cases with symptomatizing hypocalcemia admitted at Assiut University Children Hospital based on knowing the exact final diagnosis by knowing the result of the various investigations as indicated


Secondary Outcome Measures :
  1. pediatric hypocalcemia [ Time Frame: 1YEAR ]
    Recommendation for Assiut University Children Hospital for providing all the investigation required so that the patient will not need to pay for any of them if they are not done in the inpatient of the pediatric Assiut University Children Hospital at the present time of the research.



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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
: All data will be collected in a sheet form for all cases of acutely symptomatizing hypocalcemia admitted during period from 1st November 2018 to End of November 2019.
Criteria

Inclusion Criteria:

  • All symptomatizing hypocalcemic cases presenting acutely to the Assiut University Children Hospital with convulsions, carpopedal spasm, stridor, renal symptoms or malabsorption symptoms aged > 1 month to the age of 17 years.

Exclusion Criteria:

  • All neonatal hypocalcemic cases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685877


Contacts
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Contact: Safiea Abd-Elfattah Eldeeb 0882312273 SafieaEldeeb@aun.edu.eg
Contact: Yasser Farouk 01111168123 d_yaser_2009@yahoo.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Asmaa Mohammed Fathy Farghali, Profile of hypocalcemia in infants and children admitted to Assiut University Children Hospital., Assiut University
ClinicalTrials.gov Identifier: NCT03685877     History of Changes
Other Study ID Numbers: HCIIC
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance