Chevalley 2005.
Methods | STUDY DESIGN: randomised controlled trial
LOCATION AND SETTING: Community (Public Youth Health Service), Switzerland
DURATION OF SUPPLEMENTATION: 1 year
DURATION OF FOLLOW‐UP: 2 years
QUALITY ASSESSMENT: Moderate risk of bias
RANDOMISED: States random but no description
ALLOCATION CONCEALMENT: Not described or unclear
BLINDING OF SUBJECT: Unclear
DESCRIPTION OF WITHDRAWALS/DROPOUTS: Yes TYPE OF ANALYSIS: Available Data COMPLIANCE: Assessed CONFOUNDERS MEASURED: spontaneous calcium intake, physical activity, |
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Participants | N SCREENED: unknown N RANDOMISED: 235 N COMPLETED: 232 (1 year); 172 (2 years) M=100% F=0% ETHNICITY: CAUCASIAN MEAN BASELINE AGE (yrs): 7.44 BASELINE AGE RANGE (yrs): 6.5‐8.5 INCLUSION CRITERIA: healthy prepubertal, Caucasian males with spontatneous calcium intake below the 75th centile of a community sample of 990 boys EXCLUSION CRITERIA: ratio weight/height < 3rd or > 97th percentile according to Geneva reference values, presence of physical signs of puberty, chronic disease, gastro‐intestinal disease capable of inducing malabsorption, congenital or acquired bone disease, regular use of medication. BASELINE CALCIUM INTAKE (mg/day): 752 PUBERTAL STAGE: prepubertal | |
Interventions | 1. Foods supplemented by calcium phosphate milk extract (850 mg Calcium per day) 2. Unsupplemented foods CO‐INTERVENTIONS: Nil | |
Outcomes | BONE MEASURES MEASURED: SITES
AREAL BONE MINERAL DENSITY: distal radial metaphysis, diaphysis of radius, femoral neck, femoral trochanter, femoral diaphysis and L2‐4 vertebrae.
BONE MINERAL CONTENT: total body, distal radial metaphysis, diaphysis of radius, femoral neck, femoral trochanter, femoral diaphysis and L2‐4 vertebrae.
BONE AREA: distal radial metaphysis, diaphysis of radius, femoral neck, femoral trochanter, femoral diaphysis and L2‐4 vertebrae.
METHOD OF MEASUREMENT: DXA
FOLLOW‐UP ASSESSMENT POINTS(yrs): 0, 1, 2
OTHER OUTCOMES MEASURED: weight, height
BONE MEASURES INCLUDED IN ANALYSES:
AREAL BONE MINERAL DENSITY: distal radial metaphysis, diaphysis of radius, femoral neck, femoral trochanter, femoral diaphysis and L2‐4 vertebrae, mean at the 5 appendicular sites.
BONE MINERAL CONTENT: distal radial metaphysis, diaphysis of radius, femoral neck, femoral trochanter, femoral diaphysis and L2‐4 vertebrae, mean at the 5 appendicular sites.
BONE AREA: distal radial metaphysis, diaphysis of radius, femoral neck, femoral trochanter, femoral diaphysis and L2‐4 vertebrae, mean at the 5 appendicular sites. SUB‐GROUPS IDENTIFIED: physical activity levels and spontaneous calcium intake (defined by above and below median) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |