Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05074836
Status:
UNKNOWN
Last Update Posted:
2021-10-12
First Post:
2021-09-10
Brief Title:
Milk Supplementation and Bone Health in Children
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Effects of Yili Child Formula Milk on Bone Health in 4-6 Year Children a 12-month Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 NUTR56TM 195 ml 2 day II Yili regular milk pure milk 195ml2 day III Controls about 50gd grain foods containing 20-30 g carbohydrates eg 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
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 NUTR56TM 195 ml 2 day II Yili regular milk pure milk 195ml2 day III Controls about 50gd grain foods containing 20-30 g carbohydrates eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None