NCT03685877

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

March 30, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

February 26, 2019

Status Verified

September 1, 2018

Enrollment Period

Same day

First QC Date

September 24, 2018

Last Update Submit

February 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • hypocalcemia in infants and children

    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 Outcomes (1)

  • pediatric hypocalcemia

    1YEAR

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • All neonatal hypocalcemic cases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Central Study Contacts

Safiea Abd-Elfattah Eldeeb

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profile of hypocalcemia in infants and children admitted to Assiut University Children Hospital.

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 26, 2018

Study Start

March 30, 2019

Primary Completion

March 30, 2019

Study Completion

April 1, 2020

Last Updated

February 26, 2019

Record last verified: 2018-09