Methods |
DURATION OF INTERVENTION:
9 months
DURATION OF FOLLOW‐UP:
9 months
LANGUAGE OF PUBLICATION:
French |
Participants |
WHO PARTICIPATED:
French children, aged 10 to 15 years
INCLUSION CRITERIA:
hospital admission
EXCLUSION CRITERIA:
gastrointestinal or nephrological diseases or other conditions involved in the metabolism of vitamin D or phosphate
DIAGNOSTIC CRITERIA:
clinical, radiological and biochemical assessment
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
not stated |
Interventions |
NUMBER OF STUDY CENTRES:
4
COUNTRY/ LOCATION:
France, urban
SETTING:
hospital based
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
vitamin D3 100,000 IU at beginning, after 3 and after 6 month, per os
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
placebo
TREATMENT BEFORE STUDY:
not stated |
Outcomes |
PRIMARY OUTCOME(S):
calcium in blood and urine, phosphorus in blood and urine, alkaline phosphatases in blood, intact parathyroid hormone in blood, 25‐hydroxyvitamin D in blood, radiographs of the wrist
SECONDARY OUTCOMES:
no distinction made between primary and secondary outcomes |
Notes |
STATED AIM OF STUDY:
to follow the changes in calcium status and 25‐hydroxyvitamin D and parathyroid hormone levels under repeated dosis of vitamin D in winter |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |