HypomagnesemiaNCT04351451
Hypomagnesemia and Hypocalcemia Association Following Thyroidectomy
An observational study of Hypomagnesemia and Hypocalcemia, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hypomagnesemia, Hypocalcemia, Hypomagnesemia With Secondary Hypocalcemia
- What is being tested?
- thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2019to 1 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- all patients admitted for thyroidectomy -
Who cannot join
- patient with renal disease
- -
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Medicine , King Saud University
Riyadh, Central Region, 11352
About this study
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
Read more
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
Read the detailed description
Methods:
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.
Statistical analysis:
Statistical analysis was performed using statistical package for the social sciences (SPSS) version 23.0 software (SPSS Inc., Chicago ,IL,USA). If normal distributed, continuous variable were presented as mean (SD) Student t-test for paired observation was used for statistical. Pearson Chi-square test was used to compare the percentage for categorical variables. P less than 0.05 indicate statistically significant difference
- Being tested
- thyroidectomy
- Keywords
- Hypomagnesemia, Hypocalcemia, Thyroidectomy
- Medical subject headings
- Hypocalcemia, Hypomagnesemia 1, Intestinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroidectomyProcedure or surgery
total thyroidectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
hypomagnesemia post thyroidectomy
magnesium serum level less than 0.75 mmol/l
Measured: one year period
Hypocalcemia post thyroidectomy
calcium serum level less than 2.12 mmol/l
Measured: one year period
Secondary outcomes (1)
association of Hypomagnesemia and Hypocalcemia
calculate the percentage of association of both metabolic derangement post thyroidectomy
Measured: one year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypomagnesemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Abdullah Abdulkareem, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351451
- Sponsor's protocol ID
- 42CFR Part11
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypomagnesemia and Hypocalcemia Association Following Thyroidectomy
- ClinicalTrials.gov ID
- NCT04351451
- Acronym / sponsor ID
- 42CFR Part11
- Keywords
- Hypomagnesemia, Hypocalcemia, Thyroidectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Methods:
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.
Statistical analysis:
Statistical analysis was performed using statistical package for the social sciences (SPSS) version 23.0 software (SPSS Inc., Chicago ,IL,USA). If normal distributed, continuous variable were presented as mean (SD) Student t-test for paired observation was used for statistical. Pearson Chi-square test was used to compare the percentage for categorical variables. P less than 0.05 indicate statistically significant difference
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all patients admitted for thyroidectomy -
Key exclusion criteria (2 listed)
- patient with renal disease
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyroidectomytotal thyroidectomy | Procedure or surgery | – |
Primary outcome
hypomagnesemia post thyroidectomy
Time frame: one year period
magnesium serum level less than 0.75 mmol/l
Hypocalcemia post thyroidectomy
Time frame: one year period
calcium serum level less than 2.12 mmol/l
1 secondary outcome
association of Hypomagnesemia and Hypocalcemia
Time frame: one year period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypomagnesemia and Hypocalcemia, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypomagnesemia post thyroidectomy (time frame: one year period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.