Oral Nutritional Supplementation in Children

NCT02125123 | Terminated

• 1 other identifier: AL15
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Children

Outcome Measures

Primary Outcomes (1)

• Vitamin D Intake

  Change from Baseline to Week 4

Secondary Outcomes (2)

• Macronutrient Intake

  Change from Baseline to Week 4

• Micronutrient Intake

  Change from Baseline to Week 4

Study Arms (2)

Nutritional Supplement and Counseling

EXPERIMENTAL

Two servings a day; ready-to-feed nutritional supplement plus dietary counseling

Other: Nutritional Supplement and Counseling

Counseling

ACTIVE COMPARATOR

Dietary Counseling

Other: Counseling

Interventions

Nutritional Supplement and Counseling OTHER

Ready-to-feed nutritional supplement and dietary counseling

Nutritional Supplement and Counseling

Counseling OTHER

Dietary counseling

Counseling

Eligibility Criteria

• Age: 36 Months - 109 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ≥ 36 months and \< 109 months of age.
• Healthy and not suffering from any physical disability.
• Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.
• Capable of oral feeding.
• 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).
• Willing to abstain from consuming non-study nutritional supplements during the study intervention period.

You may not qualify if:

• History of an acute or chronic condition that may affect feeding habits or nutritional status.
• 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.
• Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.
• Any acute/chronic condition requiring medical treatment which may include hospitalization.
• Allergy or intolerance to any ingredient in the study product.
• Gastrointestinal infection, acute constipation or acute diarrhea.
• Hepatitis B or C, or HIV, or malignancy.
• Congenital cardiac defects.
• Dysphagia, aspiration risk or difficulty in swallowing due to acquired/congenital abnormalities.
• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (2)

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68516, United States

Location

Radiant Research, Inc.

Cincinnati, Ohio, 45249, United States

Location

MeSH Terms

Interventions

Dietary Supplements; Counseling

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jennifer Williams, MPH

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

US (2)