Courteix 2005.
Methods | STUDY DESIGN: randomised controlled trial
LOCATION AND SETTING: Community (school and sports clubs), France
DURATION OF SUPPLEMENTATION: 1 year
DURATION OF FOLLOW‐UP: 1 year
QUALITY ASSESSMENT: low risk of bias
RANDOMISED: random and description consistent with this
ALLOCATION CONCEALMENT: Yes
BLINDING OF SUBJECT: Yes
DESCRIPTION OF WITHDRAWALS/DROPOUTS: Yes TYPE OF ANALYSIS: Available Data COMPLIANCE: Assessed CONFOUNDERS MEASURED: physical activity, pubertal status, spontaneous calcium intake |
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Participants | N SCREENED: 138 N RANDOMISED: 113 N COMPLETED: 85 (1 year) M=0% F=100% ETHNICITY: CAUCASIAN MEAN BASELINE AGE (yrs): 9.91 BASELINE AGE RANGE (yrs): 8‐13 INCLUSION CRITERIA: healthy Caucasian females, age 8‐13, prepubescent and not expected to reach menarche before end of first year of study EXCLUSION CRITERIA: children with swimming as a physical activity BASELINE CALCIUM INTAKE (mg/day): 994 PUBERTAL STAGE: prepubertal | |
Interventions | 1. 800 mg/day calcium as calcium phosphate 2. Placebo CO‐INTERVENTIONS: Nil | |
Outcomes | BONE MEASURES: SITES
AREAL BONE MINERAL DENSITY: total body, dominant hip (femoral neck, trochanter and Ward's triangle), non‐dominant radius (1/3, mid and distal) and L2‐4 vertebrae.
BONE MINERAL CONTENT: total body, dominant hip (femoral neck, trochanter and Ward's triangle), non‐dominant radius (1/3, mid and distal) and L2‐4 vertebrae.
METHOD OF MEASUREMENT: DXA
FOLLOW‐UP ASSESSMENT POINTS(yrs): 0, 1
OTHER OUTCOMES MEASURED: BMI, height, bone age, fat mass, lean mass
BONE MEASURES INCLUDED IN ANALYSES:
AREAL BONE MINERAL DENSITY: total body, dominant hip (femoral neck, trochanter and Ward's triangle), non‐dominant radius (1/3, mid and distal) and L2‐4 vertebrae.
BONE MINERAL CONTENT: total body, dominant hip (femoral neck, trochanter and Ward's triangle), non‐dominant radius (1/3, mid and distal) and L2‐4 vertebrae. SUB‐GROUPS IDENTIFIED: exercise (7.2 hours exercise per week) and sedentary (1.2 hours exercise per week) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |