The effectiveness of vitamin D suppletion on improving symptoms of fatigue in children between 12 and 18 years old

Phase 1

• Conditions: Fatigue; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-000845-12-NL
• Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: A
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

- Children between 12 and 18 years old
- Referred to a hospital due to symptoms of fatigue
- Calcidiol serum level <100 nmol/L
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Comorbidities

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: An explorative pilot for determining the effectiveness of vitamine D on improving symptoms of fatigue in children between 12 and 18 years old. The amount of vitamin D will be determined by calcidiol levels at the start of inclusion. ;Secondary Objective: To determine the amount and characteristics of the children who manage to go from a calcidiol serum level of <75 nmol/L at the start of inclusion to >75 nmol/L after 3 months of vitamin D suppletion.;Primary end point(s): Primary endpoint of this study will be the difference in symptoms of fatigue as measured by the CIS-k, PedsQL and PedsQL fatigue questionnaire before and after vitamine D suppletion for three months. This will be matched to the calcidiol serum level at the start of inclusion. ;Timepoint(s) of evaluation of this end point: At 3 months after vitamin D suppletion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The amount and characteristics of the children who manage to go from a calcidiol serum level of <75 nmol/L at the start of inclusion to >75 nmol/L after 3 months of vitamin D suppletion.;Timepoint(s) of evaluation of this end point: At 3 months after vitamin D suppletion