- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685877
Hypocalcemia in Infants and Children
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
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Safiea Abd-Elfattah Eldeeb
- Phone Number: 0882312273
- Email: SafieaEldeeb@aun.edu.eg
Study Contact Backup
- Name: Yasser Farouk
- Phone Number: 01111168123
- Email: d_yaser_2009@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCIIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Hypocalcemia
-
Hospital Universitari de BellvitgeRecruitingIatrogenic HypocalcemiaSpain
-
Instituto PalaciosNexentia S.A.S.CompletedHypocalcemia; DietarySpain
-
Siriraj HospitalActive, not recruitingHypocalcemia in PregnancyThailand
-
Istanbul UniversityUnknownHypocalcemia, Postoperative ParathormoneTurkey
-
G. Hatzikosta General HospitalUnknownHypocalcemia After Total ThyroidectomyGreece
-
King Saud UniversityCompletedHypocalcemia | Hypomagnesemia | Hypomagnesemia With Secondary HypocalcemiaSaudi Arabia
-
Radboud University Medical CenterCompletedHypomagnesemia, Intestinal, With Secondary Hypocalcemia | Drug Induced Hypomagnesemia
-
Pak Emirates Military HospitalRecruiting
-
Centre Hospitalier René DubosRecruiting
-
University of MalayaUnknown