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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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ONS + dietary counseling

ONS/day + dietary counseling

Group Type EXPERIMENTAL

Nutrition supplement + dietary counseling

Intervention Type OTHER

Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.

Dietary counseling

Group Type ACTIVE_COMPARATOR

Dietary Counseling

Intervention Type OTHER

Dietary counseling provided at each study visit by study dietitian.

Interventions

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Nutrition supplement + dietary counseling

Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.

Intervention Type OTHER

Dietary Counseling

Dietary counseling provided at each study visit by study dietitian.

Intervention Type OTHER

Other Intervention Names

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Commercially available nutritional supplement.

Eligibility Criteria

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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).

Minimum Eligible Age

24 Months

Maximum Eligible Age

72 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No