Preoperative Hypocalcaemia, a Comparative Clinical Trial

NCT04212533 | Completed DMC

• 1 other identifier: hazem nour ca++
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Total Thyroidectomy

Keywords

hypocalcaemia, thyroidectomy, vit D, calcium

Outcome Measures

Primary Outcomes (2)

• number of participants with hypocalcemia

  calcium level below 8.5 mg\\dl measured by serum calcium assay

  24 hrs post operative

• number of participants with hypocalcaemia

  calcium level below 8.5 mg\\dl measured by serum calcium assay

  after 7 days post operative

Secondary Outcomes (2)

• number of participants with decreased parathormone level below normal level

  ( 1st month post operative)

• number of participants with tetany

  1 week

Study Arms (2)

supplementation arm

ACTIVE COMPARATOR

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

non-supplementation arm

ACTIVE COMPARATOR

43 patients undergoing total thyroidectomy received rice starch tablets /6 hrs in the day before surgery

Dietary Supplement: rice starch tablets

Interventions

Vitamin D DIETARY_SUPPLEMENT

comparison between pre- and postoperative calcium and vitamin d level after vit d and calcium supplementation

Also known as: calcium supplementation

supplementation arm

rice starch tablets DIETARY_SUPPLEMENT

rice starch tablets as placebo

non-supplementation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient undergoing total thyroidectomy

You may not qualify if:

• Previous thyroid surgery
• Malabsorption diseases
• Pregnancy
• Previous parathyroid disease or surgery
• Vitamin D deficiency
• Renal impairment
• Hypo or hyper calcaemia
• ASA class 3,4

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, Egypt

Location

MeSH Terms

Conditions

Hypocalcemia

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• hazem nour

  zag university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the patients dont know what they received before the operation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: two parallel groups each one 43 patients undergoing total thyroidectomy one received prophylactic vitamin d and calcium before surgery the other received nothing , calcium level, vit d levels measured preand postoperative , clinical assessment of patients postoperatie for development of tetany

Study Record Dates

• First Submitted: December 22, 2019
• First Posted: December 27, 2019
• Study Start: January 1, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)