Clinical trial NCT01823302: Effect of a New Growing-up Milk on Growth and Nutrient Adequacy in Children With Picky-eating Behaviors
Official title: Effect of a New Growing-up Milk on Growth and Nutrient Adequacy in Children With Picky-eating Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Picky Eating Behaviors
Keywords: Children with picky-eating behaviors
Children aged 2.5 - 5 years
reported by caregivers
with weight-for-height z-scores ≤ 25th percentile at enrollment
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 165
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to compare the change in z-scores for growth during a 120-day study period in children with picky eating behaviors who were randomly assigned to receive nutrition counseling only (control group) or nutrition counseling plus an oral milk-based nutritional supplement (study group). The secondary objectives of the study were to compare the following between the control and study groups: a) dietary macro- and micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia; and c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The safety objective of the study was to compare the frequency of adverse events (AE) among the control group and study group subjects.


Eligibility criteria: Inclusion Criteria:

* Children aged 30-60 months with PE behavior as reported by caregivers and whose weight-for-height was ≤25th percentile according to World Health Organization (WHO) Child Growth Standards were eligible for inclusion.

Exclusion Criteria:

* Current acute or chronic illness, food allergies, lactose intolerance, dietary restrictions precluding dairy foods, any genetic disorder that may compromise growth and/or food intake, cognitive or developmental disorders, or medications that may influence study outcomes.

Primary outcomes:
measure: Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
timeFrame: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
Secondary outcomes:
measure: Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
timeFrame: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
Other outcomes:
measure: Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
timeFrame: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
measure: •Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
timeFrame: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis
measure: •Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
timeFrame: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis
measure: •Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
timeFrame: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong
state: Shanghai
Study officials:
affiliation: Xinhua Hospital Affiliated to Shanghai Jiaotong
name: Xiaoyang Sheng, Professor
role: PRINCIPAL_INVESTIGATOR
References: