Oral Nutritional Supplementation in Children

Not Applicable

Terminated

• Conditions: Children
• Interventions: Other: Counseling; Other: Nutritional Supplement and Counseling

• Registration Number: NCT02125123
• Lead Sponsor: Abbott Nutrition

Brief Summary

This study will investigate the effect of an oral nutritional supplement (ONS) along with dietary counseling on improving the dietary intake among children with picky eating behaviors.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-24
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. ≥ 36 months and < 109 months of age.
2. Healthy and not suffering from any physical disability.
3. Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.
4. Capable of oral feeding.
5. Has a mean score of greater than 3.0 on the fussiness category in the Children's Eating Behaviour Questionnaire and also consumes on average less than the daily recommendations for at least 3 of 5 food groups (Dietary Guidelines for America, 2010).
6. Willing to abstain from consuming non-study nutritional supplements during the study intervention period.

Exclusion Criteria

1. History of an acute or chronic condition that may affect feeding habits or nutritional status.
2. Taking any medications or nutritional supplements on a daily basis for more than 2 weeks during the past month that may profoundly affect feeding habits or nutritional status.
3. Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.
4. Any acute/chronic condition requiring medical treatment which may include hospitalization.
5. Allergy or intolerance to any ingredient in the study product.
6. Gastrointestinal infection, acute constipation or acute diarrhea.
7. Hepatitis B or C, or HIV, or malignancy.
8. Congenital cardiac defects.
9. Dysphagia, aspiration risk or difficulty in swallowing due to acquired/congenital abnormalities.
10. Parent(s)/LG of the subject has any clinically significant medical disease or physical/psychological condition that may interfere with protocol adherence or ability of the parent(s)/LG to give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counseling	Counseling	Dietary Counseling
Nutritional Supplement and Counseling	Nutritional Supplement and Counseling	Two servings a day; ready-to-feed nutritional supplement plus dietary counseling

Primary Outcome Measures

Name	Time	Method
Vitamin D Intake	Change from Baseline to Week 4

Secondary Outcome Measures

Name	Time	Method
Micronutrient Intake	Change from Baseline to Week 4	24-hour dietary recall interview
Macronutrient Intake	Change from Baseline to Week 4	24-hour dietary recall interview

Trial Locations

Locations (2)

Midwest Children's Health Research Institute; 🇺🇸 Lincoln, Nebraska, United States

Radiant Research, Inc.; 🇺🇸 Cincinnati, Ohio, United States