Fatigue
Conditions
Interventions
Trade Name: Colecalciferol
Product Name: Colecalciferol
Pharmaceutical Form: Tablet
INN or Proposed INN: COLECALCIFEROL
Other descriptiv
Sponsors
Canisius Wilhelmina Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Children between 12 and 18 years old - Referred to a hospital due to symptoms of fatigue - Calcidiol serum level =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Comorbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): The amount and characteristics of the children who manage to go from a calcidiol serum level of 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 | — |
Countries
Netherlands
Contacts
Public ContactResearch Support Office
Canisius Wilhelmina Ziekenhuis
Outcome results
None listed