Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401789967358 Date of Approval: 02/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Magnesium Replacement Therapy in Altering the Course of Hypocalcaemia Post Total Thyroidectomy in Thyroid Cancer Patients
Official scientific title The Effect of Magnesium Replacement Therapy in Altering the Course of Hypocalcaemia Post Total Thyroidectomy in Thyroid Cancer Patients
Brief summary describing the background and objectives of the trial The incidence of thyroid cancer has risen dramatically over the past four decades. Because surgery is the mainstay of treatment for thyroid cancer, there is a growing interest in reducing postoperative complications. Postoperative transient hypocalcaemia is the most frequent complication after thyroidectomy, with a reported incidence of 1.6%–50%. Despite being one of the major issues post total thyroidectomy, hypocalcaemia is still a mystery and its actual reasons are not totally clear until now. Many factors have been extensively investigated as a risk factor of hypocalcaemia. One of these factors is hypomagnesaemia. Hypomagnesaemia has been associated with hypocalcaemia in chronic disease states, because it could lead to impaired parathyroid hormone (PTH) secretion and end-organ resistance to PTH which together contribute to the development of hypocalcaemia. In addition, hypomagnesaemia shares the same symptoms with hypocalcaemia. Thus, postoperative hypomagnesaemia may increase both the biochemical and symptomatic hypocalcaemia incidence in patients undergoing total thyroidectomy. The present study investigated the effect of routine magnesium replacement therapy on both hypomagnesaemia and hypocalcaemia post total thyroidectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/08/2021
Actual trial start date 01/08/2021
Anticipated date of last follow up 31/08/2022
Actual Last follow-up date 31/08/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 64
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Magnesium replacement therapy 340 mg elemental magnesium / Once daily 1500 mg equivalent of calcium / daily 1 mcg alfacalcidol / daily 14 days The treatment group were assigned to oral magnesium citrate therapy (Epimag®) by the dose of 2125 mg daily which gives around 340 mg elemental magnesium (Epimag® effervescent powder/ 1 sachet daily) in case of normal magnesium levels post-operative with regular post total thyroidectomy treatment (Ca supplements )1500 mg equivalent of calcium daily) and Vitamin D supplement (1 mcg alfacalcidol daily) for 28 days). 33
Control Group Regular post total thyroidectomy treatment 1500 mg equivalent of calcium / daily 1 mcg alfacalcidol / daily 28 days The control group were assigned to no oral magnesium supplementation with regular post total thyroidectomy treatment (Ca supplements )1500 mg equivalent of calcium daily) and Vitamin D supplement (1 mcg alfacalcidol daily) for 28 days). 31 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients suffering from hypocalcaemia post total thyroidectomy at National Cancer Institute. • At least one parathyroid gland must be preserved with normal PTH levels. • Adults only will be included (age from 18 to 65 years). • Preoperative serum calcium, magnesium, phosphorus and vitamin D levels are normal in all patients. • Infants and children (age < 18 years) • Elderly (age > 65 years) • Pregnant women • Cognitively impaired or mentally disabled subjects • Patients with history of thyroid surgeries • All parathyroid glands are lost during surgery • Severe symptomatic hypocalcaemia needing to be treated with intravenous calcium for emergency expressed as seizures or tetanic convulsions including Trousseau`s sign and Chvostek`s sign (with cut-off point of calcium level < 7 mg/dl) • Moderate and severe hypomagnesaemia (Mg level < 1.2 mg/dl) or Symptomatic hypomagnesaemia needing to be treated with intravenous magnesium for emergency (but in case of mild asymptomatic hypomagnesaemia in the treatment and the control group no special intervention or exclusion) • Patients with renal impairment ( Creatinine clearance (Crcl) < 60ml/min ) • Patients with hepatic impairment (Alanine aminotransferase (ALT) > 50 IU/L , Aspartate aminotransaminase (AST) > 40 IU/L and Total bilirubin > 1.2 mg/dl ) • Patients taking any medication that would affect calcium levels such as, Thiazide diuretics, lithium, rifampicin, phenytoin, Bisphosphonates, Dietary supplements containing calcium and vitamins affecting calcium level such as vitamin D, etc. • patients with other types of cancer other than thyroid cancer (e.g. any metastasis). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/11/2021 REC FOPCU
Ethics Committee Address
Street address City Postal code Country
Faculty of pharmacy - Kasr El Ainy St. Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The effect of magnesium replacement therapy on hypocalcaemia post total thyroidectomy. At the days 1, 2, 3, 7, 14 and 28 post-operatively
Secondary Outcome The prevalence of symptomatic hypocalcaemia post total thyroidectomy. At the days 1, 2, 3, 7, 14 and 28 post-operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute 1-Kasr El Ainy St. - Foum El Khalij Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funding 1- Kasr El Ainy St. Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Ahmed Serag 93-Othman Moharam St. Cairo Egypt Self Funding
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Serag drahmedseragsciem@gmail.com +201064449598 93-Othman moharam St.
City Postal code Country Position/Affiliation
Giza Egypt Department of Clinical Pharmacy at National Cancer Institute Cairo University
Role Name Email Phone Street address
Public Enquiries Abd El Wahab Raafat Abdalwahab.raafat@yahoo.com +201005259797 1-Kasr El Ainy St.
City Postal code Country Position/Affiliation
Cairo Egypt Department of Surgical Oncology at National Cancer Institute Cairo University
Role Name Email Phone Street address
Scientific Enquiries Maggie Abbasy maggie.abbassi@pharma.cu.edu.eg.com +201001589925 Faculty of pharmacy Kasr El Ainy St.
City Postal code Country Position/Affiliation
Cairo Egypt Department of Clinical pharmacy at Faculty of Pharmacy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlie results in a publication will be shared. Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be available immediately after publication. Anyone seeks information about this study will be able to contact the principal investigator via e-mail and the the principal investigator will respond immediately.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 17/12/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 17/12/2023 Result - 17/12/2023 Result - 17/12/2023 Result - 17/12/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information