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A Study of an Oral Nutrition Supplement (ONS) in Children.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02056275
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : March 6, 2015
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
To assess the effect of oral nutritional supplementation with dietary counseling versus dietary counseling alone on growth of preschool children over a period of 90 days.

Condition or disease Intervention/treatment Phase
Growth Other: Nutrition supplement + dietary counseling Other: Dietary Counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Study of an Oral Nutrition Supplement (ONS) in Children.
Study Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ONS + dietary counseling
ONS/day + dietary counseling
Other: Nutrition supplement + dietary counseling
Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.
Other Name: Commercially available nutritional supplement.

Active Comparator: Dietary counseling
Dietary counseling
Other: Dietary Counseling
Dietary counseling provided at each study visit by study dietitian.

Primary Outcome Measures :
  1. Weight [ Time Frame: Study Day (SD) 1 to 90 ]
    Change in weight-for-age from Day 1 to Day 90

Secondary Outcome Measures :
  1. Respiratory Infections [ Time Frame: Study Day (SD) 1 to 90 ]
    Number and duration of recurrent acute upper respiratory tract infections per month during the study period.

  2. Sick Days [ Time Frame: Study Day (SD) 1 to 90 ]
    Number of sick days per month assessed by the presence of any acute upper respiratory tract infections during the study period.

  3. Doctor Visits [ Time Frame: Study Day (SD) 1 to 90 ]
    Number of unscheduled visits per month due to development of acute upper respiratory tract infections during the study period.

  4. Dietary Intake [ Time Frame: Study Day (SD) 1 to 90 ]
    Average energy consumption (values and changes from baseline).

  5. Appetite Score [ Time Frame: Study Day (SD) 3, 10, 30, 60 and 90 ]
    Change in appetite score (values and changes from baseline)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   24 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age of 24-72 months (inclusive), both genders.
  2. Diagnosed with current acute upper respiratory tract infection.
  3. Weight-for-age between 3rd - 15th percentile according to WHO Growth Charts.
  4. Identified as a picky eater.
  5. Able to consume foods and beverages orally.
  6. Willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period.

Exclusion Criteria:

  1. Current illness requiring hospitalization.
  2. Gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study.
  3. Currently taking medication that could affect absorption/metabolism of study product or weight of the child.
  4. Diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma.
  5. Active tuberculosis, acute hepatitis B or C, or HIV, malignancy.
  6. History of diabetes mellitus.
  7. Received antibiotic therapy within the last two weeks before start of the study.
  8. Dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product.
  9. Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02056275

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St. Theresa's Hospital
Hyderabad, Andhra Pradesh, India, 500018
Praveen Cardiac Centre
Vijayawada, Andhra Pradesh, India, 520002
Sangini Hospital
Ahmedabad, Gujarat, India, 380006
Kasturba Medical College and Hospital
Manipal, Karnataka, India, 567104
Noble Hospital
Pune, Maharashtra, India, 411013
Seth GS Medical College and KEM Hospital
Mumbai-12, Mumbai, India
Institute of Child Health
Kolkata, West Bengal, India, 700 017
TN Medical College & BYL Nair Hospital
Mumbai, India, 400 008
Sponsors and Collaborators
Abbott Nutrition
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Study Chair: Vinita Satyavrat, MD Abbott Nutrition
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Responsible Party: Abbott Nutrition Identifier: NCT02056275    
Other Study ID Numbers: DA01
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: October 2014