Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD) |
Serum 25-OH-VD |
0, 6 and 12 months |
|
Other |
Concentrations of blood parathyroid Hormone (PTH) |
Serum PTH |
0, 6 and 12 months |
|
Other |
Nutritional status 1: Body weight |
Body weight (in kg) |
0, 4, 8 and 12 months |
|
Other |
Nutritional status 2: waist circumference |
Waist circumference (in cm) |
0, 4, 8 and 12 months |
|
Other |
Nutritional status 3: middle-arm circumference |
Middle-arm circumference (in cm) |
0, 4, 8 and 12 months |
|
Other |
Nutritional status 4: skinfold thickness |
Skinfold thickness (in mm) |
0, 4, 8 and 12 months |
|
Other |
Total consumption of milk and dairy food |
Total consumption of milk and dairy food (in ml/d) |
0, 4, 8 and 12 months |
|
Other |
Consumption of dietary energy |
Consumption of dietary energy (in kcal/d) |
0, 4, 8 and 12 months |
|
Other |
Consumption of dietary protein |
Consumption of dietary protein (in g/d) |
0, 4, 8 and 12 months |
|
Other |
Consumption of dietary calcium |
Consumption of dietary calcium (in mg/d) |
0, 4, 8 and 12 months |
|
Other |
Number of participants with treatment-related adverse events |
Adverse events : assessed by using questionnaires of medical conditions, medications related to milk intake |
0, 4, 8 and 12 months |
|
Other |
Child behaviors |
Child behaviours: assessed by using a Child behavior Questionnaire-- parent version. The minimum and maximum values: 26-78; higher scores mean worse outcome. |
0 and 12 months |
|
Other |
Physical activity |
Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire |
0, 4, 8 and 12 months |
|
Other |
Concentrations of serum calcium |
Serum calcium (mmol/L) |
0, 6 and 12 months |
|
Primary |
Change from baseline bone mineral density (BMD) at 12 months |
BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel |
0 and 12 months |
|
Primary |
Change from baseline bone mineral density (BMD) at 6 months |
BMD (g/cm2) determined by DXA at the left forearm and heel |
0 and 6 months |
|
Primary |
Change from baseline bone mineral contents (BMC) at 12 months |
BMC (g) determined by DXA at the left forearm and heel. |
0 and 12 months |
|
Primary |
Change from baseline bone mineral contents (BMC) at 6 months |
BMC (g) determined by DXA at the left forearm and heel. |
0 and 6 months |
|
Primary |
Change from baseline of bone-specific alkaline phosphatase at 12 months |
Bone turnover marker 1: Bone-specific alkaline phosphatase |
0 and 12 months |
|
Primary |
Change from baseline of bone-specific alkaline phosphatase at 6 months |
Bone turnover marker 1: Bone-specific alkaline phosphatase |
0 and 6 months |
|
Primary |
Change from baseline of osteocalcin at 12 months |
Bone turnover marker 2: osteocalcin |
0 and 12 months |
|
Primary |
Change from baseline of osteocalcin at 6 months |
Bone turnover marker 2: osteocalcin |
0 and 6 months |
|
Primary |
Change from baseline of C-terminal telopeptide of type I collagen at 12 months |
Bone turnover marker 3: C-terminal telopeptide of type I collagen |
0 and 12 months |
|
Primary |
Change from baseline of C-terminal telopeptide of type I collagen at 6 months |
Bone turnover marker 3: C-terminal telopeptide of type I collagen |
0 and 6 months |
|
Primary |
Change from baseline of tartrate resistant acid phosphatase at 12 months |
Bone turnover marker 4: tartrate resistant acid phosphatase |
0 and 12 months |
|
Primary |
Change from baseline of tartrate resistant acid phosphatase at 6 months |
Bone turnover marker 4: tartrate resistant acid phosphatase |
0 and 6 months |
|
Secondary |
Change from baseline body weight at 12 months |
Anthropometric indices: body weight |
0 and 12 months |
|
Secondary |
Change from baseline body height at 12 months |
Anthropometric indices: body height |
0 and 12 months |
|
Secondary |
Change from baseline biomarker of body growth at 12 months |
Biomarker of body growth: insulin-like growth factor 1 |
0 and 12 months |
|
Secondary |
Change from baseline immune globulin M (Ig M)at 12 months |
Immune status: Blood Ig M |
0 and 12 months |
|
Secondary |
Change from baseline immune globulin G (Ig G)at 12 months |
Immune status: Blood Ig G |
0 and 12 months |
|
Secondary |
Change from baseline immune globulin G (Ig A)at 12 months |
Immune status: Blood Ig A |
0 and 12 months |
|
Secondary |
Change from baseline whit blood cell at 12 months |
Immune status: whit blood cell |
0 and 12 months |
|