No registrations found.
ID
Source
Health condition
Fatigue
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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.
Background summary
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.
Study objective
The calculated loading dose, follow by a daily dose of vitamine D will particularly improve symptoms of fatigue in patients with a calcidiol serum level below 50 nmol/L.
Study design
At t=0 the calcidiol serum level will be determined and the CIS-k, PedsQL and PedsQL fatigue questionnaire will be performed.
After 3 months of vitamin D suppletion, the child will revisit the hospital to determine the calcidiol serum level again and the CIS-k, PedsQL and PedsQL fatigue questionnaire will be performed once more.
Intervention
Vitamin D/colecalciferol
Inclusion criteria
- Children between 12 and 18 years old
- Referred to a hospital due to symptoms of fatigue
- Calcidiol serum level <100 nmol/L
Exclusion criteria
- Comorbidities
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7540 |
| Other | CMO Arnhem-Nijmegen : 2019-5234 |