NCT03582917

Brief Summary

The purpose of this current prospective study is to determine the role of vitamin D in the development and restoration of spinal deformities in adolescence.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

7.3 years

First QC Date

May 29, 2018

Last Update Submit

December 4, 2024

Conditions

Scoliosis; Adolescence

Outcome Measures

Primary Outcomes (4)

  • 25(OH)D

    Measurement of the major metabolite of vitamin D

    48 weeks

  • X - rays

    Cobb angle measurement

    48 weeks

  • Dexa

    BMD and Z - score measurement

    48 weeks

  • BMD (weight in kilograms, height in meters)

    weight and height will be combined to report BMI in kg/m\^2

    48 weeks

Study Arms (2)

Alphacalscidol

EXPERIMENTAL

0,5mg tablet by mouth, one each day for one year

Drug: Alphacalcidol

No treatment

NO INTERVENTION

Interventions

AlphacalcidolDRUG

Alphacalcidol 0,5mg tablet

Alphacalscidol

Eligibility Criteria

Age10 Years - 18 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPatients will be boys aged 10 to 18 and girls 10 to 16
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Idiopathic Adolescent Scoliosis
  • Risser sign \<3-4

You may not qualify if:

  • Neuromuscular diseases
  • metabolic disease
  • Liver, lung, thyroid and parathyroid gland disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Papanikolaou General Hospital

Asvestochóri, Greece

RECRUITING

Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina

Ioannina, 45100, Greece

RECRUITING

MeSH Terms

Conditions

Scoliosis

Interventions

alfacalcidol

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Lazaros Tagkalidis

CONTACT

+30 6977252028akissdoc@hotmail.com

Avraam Ploumis, Ass. Professor

CONTACT

6932080701aploumis@uoi.gr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of PMR, Orthopaedic Spine Surgeon

Study Record Dates

First Submitted

May 29, 2018

First Posted

July 11, 2018

Study Start

September 20, 2018

Primary Completion

December 20, 2025

Study Completion

December 20, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

GR(2)