- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05074836
Milk Supplementation and Bone Health in Children
Effects of Yili Child Formula Milk on Bone Health in 4-6 Year Children: a 12-month Randomized Controlled Trial
Objectives: to examine the effects of a Yili child formula milk and regular milk on bone health and growth in young children.
Study design: cluster randomized controlled trial.
Setting: kindergartens in Hui-ning County of Gansu Province, China (north west).
Participants: >=246 apparent healthy children aged 4-6 years old.
Interventions:
(I) Yili child formula milk (QQ star formula, SCI-PRO NUTR5+6TM), 195 ml *2 /day; (II) Yili regular milk (pure milk), 195ml*2 /day; (III) Controls: about 50g/d grain foods (containing 20-30 g carbohydrates), e.g. bread.
Interventional Duration: 12 months.
Outcome measures: determined at 0, 6 and 12 months post treatments. Primary outcomes: bone density and bone mineral contents at the forearm and heel, bone biomarkers.
Secondary outcomes: (1) anthropometric indices: weight, height, waist circumference, etc.; (2) immune status.
Other measures: dietary intakes, physical activities, general information, medical information, adverse of side effects.
Data Analyses: The one-year changes and percent changes in the primary and secondary outcomes will be compared among the 3 groups.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Gangshu
-
Lanzhou, Gangshu, Chine, 730000
- LanZhou University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Aged between 4-6 years;
- female and male
- Can be enrolled into kindergarten/school as a normal child.
- Be willing to drinking milk daily.
Exclusion Criteria:
- Milk allergy or intolerance, did not to be used to drinking milk;
- Had the following diseases/conditions confirmed by a hospital: serious diseases of heart, liver, kidney, brain, hematopoietic system, immunity, thyroid or cancer that need to be hospitalization for more than 1 week or take medication(s) for more than 1 month with the past two years.
- having infectious diseases, e.g., tuberculosis, hepatitis, etc.
- Taking vitamin D, calcium tables or nutrient package;
- Consumed more than 3 times (>600ml) milk each week in the previous month.
- Be not willing to provide informed consent, or have other conditions that were considered to be unsuitable for the study by the investigators.
- Increases of body health were out of the range between 5-8 cm in the last year.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Formula Milk
Formula milk designed for young children aged over 3 years; Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
Brand name: Yili (QQ star formula milk); Type: SCI-PRO NUTRI 5+6TM formula milk designed for young children aged over 3 years; Dosage: 195ml*2/d; Intervention duration: 12 months |
Comparateur actif: Regular milk
Regular milk (pure milk); Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
Brand name: Yili; Type: regular milk (pure milk); Dosage: 195ml*2/d; Intervention duration: 12 months |
Autre: Control foods
Grain foods: e.g., bread; Dosage: 20-40 g/time; Frequence: 2 times /day; Duration: 12 months |
Brand: N/A; Food type: grain foods (e.g., bread); Dosage: 20-40g * 2/d grain foods Intervention duration: 12 months |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from baseline bone mineral density (BMD) at 12 months
Délai: 0 and 12 months
|
BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel
|
0 and 12 months
|
Change from baseline bone mineral density (BMD) at 6 months
Délai: 0 and 6 months
|
BMD (g/cm2) determined by DXA at the left forearm and heel
|
0 and 6 months
|
Change from baseline bone mineral contents (BMC) at 12 months
Délai: 0 and 12 months
|
BMC (g) determined by DXA at the left forearm and heel.
|
0 and 12 months
|
Change from baseline bone mineral contents (BMC) at 6 months
Délai: 0 and 6 months
|
BMC (g) determined by DXA at the left forearm and heel.
|
0 and 6 months
|
Change from baseline of bone-specific alkaline phosphatase at 12 months
Délai: 0 and 12 months
|
Bone turnover marker 1: Bone-specific alkaline phosphatase
|
0 and 12 months
|
Change from baseline of bone-specific alkaline phosphatase at 6 months
Délai: 0 and 6 months
|
Bone turnover marker 1: Bone-specific alkaline phosphatase
|
0 and 6 months
|
Change from baseline of osteocalcin at 12 months
Délai: 0 and 12 months
|
Bone turnover marker 2: osteocalcin
|
0 and 12 months
|
Change from baseline of osteocalcin at 6 months
Délai: 0 and 6 months
|
Bone turnover marker 2: osteocalcin
|
0 and 6 months
|
Change from baseline of C-terminal telopeptide of type I collagen at 12 months
Délai: 0 and 12 months
|
Bone turnover marker 3: C-terminal telopeptide of type I collagen
|
0 and 12 months
|
Change from baseline of C-terminal telopeptide of type I collagen at 6 months
Délai: 0 and 6 months
|
Bone turnover marker 3: C-terminal telopeptide of type I collagen
|
0 and 6 months
|
Change from baseline of tartrate resistant acid phosphatase at 12 months
Délai: 0 and 12 months
|
Bone turnover marker 4: tartrate resistant acid phosphatase
|
0 and 12 months
|
Change from baseline of tartrate resistant acid phosphatase at 6 months
Délai: 0 and 6 months
|
Bone turnover marker 4: tartrate resistant acid phosphatase
|
0 and 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from baseline body weight at 12 months
Délai: 0 and 12 months
|
Anthropometric indices: body weight
|
0 and 12 months
|
Change from baseline body height at 12 months
Délai: 0 and 12 months
|
Anthropometric indices: body height
|
0 and 12 months
|
Change from baseline biomarker of body growth at 12 months
Délai: 0 and 12 months
|
Biomarker of body growth: insulin-like growth factor 1
|
0 and 12 months
|
Change from baseline immune globulin M (Ig M)at 12 months
Délai: 0 and 12 months
|
Immune status: Blood Ig M
|
0 and 12 months
|
Change from baseline immune globulin G (Ig G)at 12 months
Délai: 0 and 12 months
|
Immune status: Blood Ig G
|
0 and 12 months
|
Change from baseline immune globulin G (Ig A)at 12 months
Délai: 0 and 12 months
|
Immune status: Blood Ig A
|
0 and 12 months
|
Change from baseline whit blood cell at 12 months
Délai: 0 and 12 months
|
Immune status: whit blood cell
|
0 and 12 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD)
Délai: 0, 6 and 12 months
|
Serum 25-OH-VD
|
0, 6 and 12 months
|
Concentrations of blood parathyroid Hormone (PTH)
Délai: 0, 6 and 12 months
|
Serum PTH
|
0, 6 and 12 months
|
Nutritional status 1: Body weight
Délai: 0, 4, 8 and 12 months
|
Body weight (in kg)
|
0, 4, 8 and 12 months
|
Nutritional status 2: waist circumference
Délai: 0, 4, 8 and 12 months
|
Waist circumference (in cm)
|
0, 4, 8 and 12 months
|
Nutritional status 3: middle-arm circumference
Délai: 0, 4, 8 and 12 months
|
Middle-arm circumference (in cm)
|
0, 4, 8 and 12 months
|
Nutritional status 4: skinfold thickness
Délai: 0, 4, 8 and 12 months
|
Skinfold thickness (in mm)
|
0, 4, 8 and 12 months
|
Total consumption of milk and dairy food
Délai: 0, 4, 8 and 12 months
|
Total consumption of milk and dairy food (in ml/d)
|
0, 4, 8 and 12 months
|
Consumption of dietary energy
Délai: 0, 4, 8 and 12 months
|
Consumption of dietary energy (in kcal/d)
|
0, 4, 8 and 12 months
|
Consumption of dietary protein
Délai: 0, 4, 8 and 12 months
|
Consumption of dietary protein (in g/d)
|
0, 4, 8 and 12 months
|
Consumption of dietary calcium
Délai: 0, 4, 8 and 12 months
|
Consumption of dietary calcium (in mg/d)
|
0, 4, 8 and 12 months
|
Number of participants with treatment-related adverse events
Délai: 0, 4, 8 and 12 months
|
Adverse events : assessed by using questionnaires of medical conditions, medications related to milk intake
|
0, 4, 8 and 12 months
|
Child behaviors
Délai: 0 and 12 months
|
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
|
Physical activity
Délai: 0, 4, 8 and 12 months
|
Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire
|
0, 4, 8 and 12 months
|
Concentrations of serum calcium
Délai: 0, 6 and 12 months
|
Serum calcium (mmol/L)
|
0, 6 and 12 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Yuming Chen, Ph.D., Sun Yat-sen University
- Chaise d'étude: Zhifu Zhao, M. Phil, Inner Mongolia Dairy Technology Research Institute Co., Ltd.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SYSU-51000-20210723-0001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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