NCT02664857

Brief Summary

In this study, effect of vitamin D supplementation on postoperative pain and sedation-agitation will investigate. Children with mental motor retardation between 7-17 age which dental treatment will be performed under general anaesthesia will be included in this study. 600 IU vitamin D will apply to group D per orally during 12 weeks. Group P will not take anything during 12 weeks. At first day and end of the 12 weeks, serum vitamin D, calcium level will evaluate. At the end of the 12 weeks general anaesthesia will be performed for teeth check up, flouring, scaling polishing, tooth extraction, filling applications, amputations, root canal treatment. After then postoperative pain, sedation and agitation will be evaluate. All data will be statistically evaluate at the end of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 21, 2021

Status Verified

January 1, 2021

Enrollment Period

4.4 years

First QC Date

January 20, 2016

Last Update Submit

April 20, 2021

Conditions

Postoperative Pain

Keywords

Vitamin DPostoperative PainMental Motor Retardation

Outcome Measures

Primary Outcomes (1)

  • Non-communicating Children's Pain Checklist - Postoperative Version

    The subjects will evaluate per 15 minutes for 1 hour.

    At Postoperative period for first 1 hour

Secondary Outcomes (2)

  • vitamin D level

    At first day and end of the 12 weeks

  • Postoperative sedation-agitation

    At postoperative first hour

Study Arms (2)

vitamin D

ACTIVE COMPARATOR

After per orally vitamin D supplementation during 12 weeks, serum Vitamin D level will evaluate with laboratory testing. 600 IU vitamin D will apply to 30 subject during 12 weeks. At first day end end of the 12 weeks serum vitamin D level will analyse with laboratory testing.End of the 12 weeks, the children will be perform dental treatment under general anaesthesia. Postoperative pain, anxiety and sedation will evaluate.

Drug: Vitamin D

Placebo

SHAM COMPARATOR

Grup P will not take vitamin D during 12 weeks. This group just only will follow by researchers.At first day end end of the 12 weeks serum vitamin D level will analyse with laboratory testing.End of the 12 weeks, the children will be perform dental treatment under general anaesthesia. Postoperative pain, anxiety and sedation will evaluate.

Drug: Placebo

Interventions

Vitamin DDRUG

Group D will take 600 IU vitamin D per orally during 12 weeks. At first day and end of the 12 weeks serum vitamin D level will analyse with laboratory testing

Also known as: vitamin D supplementation
vitamin D
PlaceboDRUG

Group P will not take orally during 12 weeks. This group will only observe by researchers.

Also known as: Observed group
Placebo

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Mentally and motor retarded children
  • dental treatment under general anaesthesia

You may not qualify if:

  • normally children(not MMR)
  • The persons who not accept the including study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Dilek Ozcengiz, Professor

    Cokurova University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 27, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 21, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)