An interventional study of Vitamin D and rice starch tablets in Total Thyroidectomy, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-27.
Sponsored by Zagazig University · Not applicable, Interventional, and Prevention
two groups of patients undergoing total thyroidectomy one group received calcium and vit d prophylaxis the other group received no prophylaxis the investigator measured calcium level post and preoperative and development of tetant was recorded
This study is randomized controlled trial carried out on 86 patients undergoing total thyroidectomy in the period between January 2018 and November 2019. Patients were randomly allocated into two groups each one 43 patients the first group is the supplementation group where patients received oral vitamin D 40000 IU and calcium tablets 1 g once before surgery.
Patient included in this study are those above 18 years old undergoing total thyroidectomy.
Patients excluded from this study are those with
all patients in this study were subjected to thorough history taking full clinical examination, body mass index calculation, proper assessment of the original thyroid disease requiring surgery, preoperative investigations done as usual in addition to serum calcium, serum magnesium, serum vitamin D and serum parathormon level.
Serum calcium and serum parathormon were tested after 6, 12 and 48 postoperative hours, patients were discharged on the third postoperative day except if further hospitalization was indicated, after discharge patients were followed up in the outpatient clinic by one of the surgical team, serum calcium and parathormon level were tested after1 months, 3 months and after 6th months.
The primary outcome of this study is the development of hypocalcaemia either clinically or laboratory.
Clinical hypocalcaemia means development of perioral and \ or acral tingling and numbness, twitches of the perioral region on tapping in front of the ear" Chvostec's sign'', muscle twitches and development of carpopedal spasm.
Laboratory hypocalcaemia means serum calcium level below 8.5 mg\dl. Secondary outcome is the postoperative parathormon level. Preoperative data, postoperative clinical follow up and laboratory data were collected and analyzed using SPSS 22 program package.
Principles of total thyroidectomy; Total thyroidectomy was performed under general anesthesia, through lower neck collar incision, skin and platysma muscle flap was raised till the thyroid cartilage, opening the midline raphe, exploration of each thyroid lobe and tracing the inferior thyroid artery while emerging from underneath the carotid artery, the inferior thyroid artery was identified with its branches supplying the parathyroid gland, which was identified and preserved with its blood supply, the recurrent laryngeal nerve was searched for in the triangle between the carotid artery , trachea and the inferior thyroid artery. The external laryngeal nerve was identified and preserved 1 cm superior to the upper thyroid pole. If radical thyroidectomy was deemed the same principles of preserving parathyroid glands and their blood supply, recurrent and external laryngeal nerves. If the surgeons ere sure of damaging or removing the parathyroid glands a half of one of them was minced and transplanted in the subcutaneous tissue of the left forearm
83 studies on the registry are indexed under Hypocalcemia; 15 are open to participants now.
This study's enrollment of 86 is close to the median of 84 across 54 interventional studies indexed under Hypocalcemia.
Browse Hypocalcemia studies →Zagazig University is the lead sponsor of 457 studies on the registry; 77 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
43 patients undergoing total thyroidectomy received 40000 IU vit D and once before operation and 500mg calcium tab 4 times in the day before surgery
Dietary Supplement: Vitamin D
43 patients undergoing total thyroidectomy received rice starch tablets /6 hrs in the day before surgery
Dietary Supplement: rice starch tablets
comparison between pre- and postoperative calcium and vitamin d level after vit d and calcium supplementation
Also known as: calcium supplementation
rice starch tablets as placebo
number of participants with hypocalcemia
calcium level below 8.5 mg\\dl measured by serum calcium assay
Time frame: 24 hrs post operative
number of participants with hypocalcaemia
calcium level below 8.5 mg\\dl measured by serum calcium assay
Time frame: after 7 days post operative
number of participants with decreased parathormone level below normal level
level of parathormone below 10 pg/mL
Time frame: ( 1st month post operative)
number of participants with tetany
development of tingling, numbness or carpopedal spasm measured by clinical examination and patient history
Time frame: 1 week
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Dec 2019, 23 months.
Of 18 interventional studies with no phase under Hypocalcemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's 23 months is close to that.
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin D