Hypocalcemia in Infants and Children

February 23, 2019 updated by: Asmaa Mohammed Fathy Farghali, Assiut University

Profile of Hypocalcemia in Infants and Children Admitted to Assiut University Children Hospital

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).

Study Overview

Status

Unknown

Conditions

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)

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 17 years (CHILD)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1YEAR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1YEAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 30, 2019

Primary Completion (ANTICIPATED)

March 30, 2019

Study Completion (ANTICIPATED)

April 1, 2020

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (ACTUAL)

September 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 23, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • HCIIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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