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OpenTrials
Completed

NCT Number: NCT02056275

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

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.

Completed

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Key information

Conditions

Age range

24 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Theresa's Hospital, Hyderabad, Andhra Pradesh, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Current illness requiring hospitalization.
  • Gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study.
  • Currently taking medication that could affect absorption/metabolism of study product or weight of the child.
  • 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.
  • Active tuberculosis, acute hepatitis B or C, or HIV, malignancy.
  • History of diabetes mellitus.
  • Received antibiotic therapy within the last two weeks before start of the study.
  • Dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product.
  • Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product).

Treatment and study plan

Nutrition supplement + dietary counseling

Other

Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.

Other names: Commercially available nutritional supplement.

Dietary Counseling

Other

Dietary counseling provided at each study visit by study dietitian.

Primary outcomes

  1. Weight

    Time frame: Study Day (SD) 1 to 90

    Change in weight-for-age from Day 1 to Day 90

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2014
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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