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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02056275
Other study ID # DA01
Secondary ID
Status Completed
Phase N/A
First received February 4, 2014
Last updated March 5, 2015
Start date August 2013
Est. completion date April 2014

Study information

Verified date October 2014
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 256
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 24 Months to 72 Months
Eligibility 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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Nutrition supplement + dietary counseling
Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.
Dietary Counseling
Dietary counseling provided at each study visit by study dietitian.

Locations

Country Name City State
India Sangini Hospital Ahmedabad Gujarat
India St. Theresa's Hospital Hyderabad Andhra Pradesh
India Institute of Child Health Kolkata West Bengal
India Kasturba Medical College and Hospital Manipal Karnataka
India TN Medical College & BYL Nair Hospital Mumbai
India Seth GS Medical College and KEM Hospital Mumbai-12 Mumbai
India Noble Hospital Pune Maharashtra
India Praveen Cardiac Centre Vijayawada Andhra Pradesh

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Change in weight-for-age from Day 1 to Day 90 Study Day (SD) 1 to 90 No
Secondary Respiratory Infections Number and duration of recurrent acute upper respiratory tract infections per month during the study period. Study Day (SD) 1 to 90 No
Secondary Sick Days Number of sick days per month assessed by the presence of any acute upper respiratory tract infections during the study period. Study Day (SD) 1 to 90 No
Secondary Doctor Visits Number of unscheduled visits per month due to development of acute upper respiratory tract infections during the study period. Study Day (SD) 1 to 90 No
Secondary Dietary Intake Average energy consumption (values and changes from baseline). Study Day (SD) 1 to 90 No
Secondary Appetite Score Change in appetite score (values and changes from baseline) Study Day (SD) 3, 10, 30, 60 and 90 No
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