NCT02056275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

February 4, 2014

Last Update Submit

March 5, 2015

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • Weight

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

    Study Day (SD) 1 to 90

Secondary Outcomes (5)

  • Respiratory Infections

    Study Day (SD) 1 to 90

  • Sick Days

    Study Day (SD) 1 to 90

  • Doctor Visits

    Study Day (SD) 1 to 90

  • Dietary Intake

    Study Day (SD) 1 to 90

  • Appetite Score

    Study Day (SD) 3, 10, 30, 60 and 90

Study Arms (2)

ONS + dietary counseling

EXPERIMENTAL

ONS/day + dietary counseling

Other: Nutrition supplement + dietary counseling

Dietary counseling

ACTIVE COMPARATOR

Dietary counseling

Other: Dietary Counseling

Interventions

Nutrition supplement + dietary counselingOTHER

Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.

Also known as: Commercially available nutritional supplement.
ONS + dietary counseling
Dietary CounselingOTHER

Dietary counseling provided at each study visit by study dietitian.

Dietary counseling

Eligibility Criteria

Age24 Months - 72 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Current illness requiring hospitalization.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

St. Theresa's Hospital

Hyderabad, Andhra Pradesh, 500018, India

Location

Praveen Cardiac Centre

Vijayawada, Andhra Pradesh, 520002, India

Location

Sangini Hospital

Ahmedabad, Gujarat, 380006, India

Location

Kasturba Medical College and Hospital

Manipal, Karnataka, 567104, India

Location

Noble Hospital

Pune, Maharashtra, 411013, India

Location

TN Medical College & BYL Nair Hospital

Mumbai, Mumbai, 400 008, India

Location

Seth GS Medical College and KEM Hospital

Mumbai-12, Mumbai, India

Location

Institute of Child Health

Kolkata, West Bengal, 700 017, India

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Vinita Satyavrat, MD

    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

February 4, 2014

First Posted

February 5, 2014

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 6, 2015

Record last verified: 2014-10

Locations

IN(8)