NCT04351451

Brief Summary

Magnesium plays a role in the active transport of calcium (Ca+2) and potassium ions across cell membranes. Most of it is intracellular or in the bone , however less than 1% of magnesium is in the blood serum. Hypoparathyroidism post thyroidectomy leads to acute Hypocalcemia that leads to hypomagnesemia. The relation of Ca+2 and magnesium (Mg+2) metabolism is complex and mainly related to the interaction of these cations with parathyroid post thyroidectomy. (Mg+2) is an essential regulator of Ca+2 flux and intracellular action of Ca+2. Hypomagnesaemia impairs hypocalcaemia induced PTH release, which is corrected rapidly after magnesium replacement. Attempting to correct only hypocalcemia may prolong symptoms. It is important to monitor both Ca+2 \& Mg+2 levels following thyroidectomy to facilitate prompt resolution of symptoms. Aim of the study: is to highlight the prevalence of hypomagnesemia following thyroidectomy and its association with hypocalcemia which mandate early recognition and treatment to prevent prolongation of hypocalcemia and permanent hypoparathyroidism Methods: IRB obtained (E20-4615) informed consent taken from all patient. This is prospective open Label observational study in patients underwent thyroidectomy .the study period was from January 2019 to January 2020. Total of 74 patients with normal renal function. Corrected serum Ca+2, magnesium, phosphate level and vitamin D level are all checked pre operatively and in the first post-operative day. Result: Post thyroidectomy 56.8% of patients had hypomagnesemia. 59.5.1% patients had hypocalcemia and 41.9% of patients had low both Ca+2 and Mg+2 (P=0.004) Conclusion: Hypocalcemia and hypomagnesemia following thyroidectomy is of multi factorial related mainly to Ca+2, Mg+2 interaction. Keywords: Hypomagnesemia. Hypocalcemia. Thyroidectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 12, 2020

Last Update Submit

April 15, 2020

Conditions

Keywords

HypomagnesemiaHypocalcemiaThyroidectomy

Outcome Measures

Primary Outcomes (2)

  • hypomagnesemia post thyroidectomy

    magnesium serum level less than 0.75 mmol/l

    one year period

  • Hypocalcemia post thyroidectomy

    calcium serum level less than 2.12 mmol/l

    one year period

Secondary Outcomes (1)

  • association of Hypomagnesemia and Hypocalcemia

    one year period

Interventions

thyroidectomyPROCEDURE

total thyroidectomy

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A prospective study for 1 year starting 1/1/2019 to 1/1/2020. A total 74 patients with normal renal function .admitted for thyroidectomy. Preoperative serum calcium, magnesium, phosphate and vitamin D level all checked. Postoperatively corrected serum calcium, magnesium and phosphate level are checked. The serum calcium less than 2.12mmol/l is corrected with oral or IV calcium infusion plus vitamin D depending on the severity of symptoms. Any serum magnesium less than 0.75mmol/l is corrected with infusion magnesium sulfate. Calcium and magnesium level monitored and corrected according to the result.

You may qualify if:

  • all patients admitted for thyroidectomy -

You may not qualify if:

  • patient with renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine , King Saud University

Riyadh, Central Region, 11352, Saudi Arabia

Location

MeSH Terms

Conditions

HypocalcemiaHypomagnesemia 1, Intestinal

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant&assistant professor

Study Record Dates

First Submitted

April 12, 2020

First Posted

April 17, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations