Health TrialsbyHealthPanel

Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

ConditionHypocalcemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital NOVO

About this trial

This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient ≥ 18 years old

Patient shall be operated on for a total thyroidectomy in one time for any indication

Written informed consent (IC) obtained

Patients with affiliation to the social security system

Disqualifiers

Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia, hypercalcemia/ hypercalciuria, not due to thyroid pathologies

Chronic kidney disease grade ≥4

Severe liver failure

25OHD supplementation within last 3 months before surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D

    Drug

    Patients will receive a cholecalciferol supplementation added to a fruit juice.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Vitamin DExperimental treatment 1 intervention
Group B: Fruit juiceNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy

Measure of the occurrence of serum and / or clinical hypocalcemia. Serum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L. Clinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and day 15

Time frame
At Day 15 after surgery

Secondary outcomes

1

Comparison of clinical course in both Arm

Clinical course will be measured, for several items, and compared between both groups to see if a significant difference is observed. Items, considered for comparison, are listed below : * Initial hospital stay (number of days), * number of readmission, * adverse event (number)

Time frame
At 3 month
2

Comparison of severity of hypocalcemia in both arm

The severity of hypocalcemia will be measured in both arm, to see if a significant difference is observed, with items listed below : * Calcemia, corrected for albuminemia, of less than 1.90 mmol / L * the use of calcium gluconate IV in the first 15 post-operative days) * duration of hypocalcemia's symptoms in the first 15 days postoperative

Time frame
At Day 1, Day 2 and Day 15
3

Comparison of the effect of supplementation on vitamin D deficiency in both arm

Comparison between measured initial value of 25OHD at the inclusion visit to the measured value of 25OHD on the day of the operation in both groups.

Time frame
At Day 0
4

Comparison of parathyroid activity in both arm

Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH \< 15 ng / L.

Time frame
At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hôpital NOVO

Lead sponsor

Source ClinicalTrials.gov
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