NCT02523027

Brief Summary

This study will investigate the effect of two oral nutritional supplements (ONS) along with dietary counseling vs dietary counseling alone on growth among picky eating children from India, aged \> 24 months to ≤ 48 months 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
321

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

11 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

First Submitted

Initial submission to the registry

August 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

June 21, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

August 12, 2015

Last Update Submit

March 12, 2018

Conditions

Children - Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Change in WHO weight-for-height percentile

    Day 1 to Day 90

Secondary Outcomes (10)

  • Change in weight-for-height WHO z-score

    Day 1 to Day 90

  • Change in weight-for-age WHO z-score and percentile

    Day 1 to Day 90

  • Change in height-for-age WHO z-score and percentile

    Day 1 to Day 90

  • Change in BMI-for-age WHO z-score and percentile

    Day 1 to Day 90

  • Change in Mid Upper Arm Circumference-for-age WHO z-score and percentile

    Day 1 to Day 90

  • +5 more secondary outcomes

Study Arms (3)

Experimental Group 1:

EXPERIMENTAL

Oral nutritional supplement (List No S691/Z0) and dietary counseling

Dietary Supplement: Oral nutritional supplement (List No S691/Z0)Other: Dietary Counselling

Experimental Group 2

EXPERIMENTAL

Oral nutritional supplement (List No- P968/Z0) and dietary counseling.

Dietary Supplement: Oral nutritional supplementOther: Dietary Counselling

Control Group

NO INTERVENTION

Dietary Counselling only.

Interventions

Oral nutritional supplement (List No S691/Z0)DIETARY_SUPPLEMENT

(List No S691/Z0)

Experimental Group 1:
Oral nutritional supplementDIETARY_SUPPLEMENT

(List No- P968/Z0)

Experimental Group 2
Dietary CounsellingOTHER

Regular dietary counseling conducted by a trained hospital dietitian.

Experimental Group 1:Experimental Group 2

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child is \> 24 months and ≤ 48 months of age at visit 1.
  • Child of either gender (Male and Female).
  • Child has a weight-for-height between 3rd - 15th percentiles according to current WHO Growth Charts at visit 1. (WHO Growth Chart 2007)
  • Child is a picky eater, defined as meeting at least two of the following criteria. A child, who:
  • eats only a limited number of foods
  • is unwilling to try new foods
  • refuses to eat vegetables and/or foods from other food groups
  • shows strong food likes and dislikes
  • has behaviors that disrupt mealtime
  • Child is a habitual milk drinker at least 1 glass (approximately 200mL) of milk daily.
  • Child is able to consume foods and beverages orally.
  • Child's Legal Guardian (LG) or parent(s) is willing to abstain from giving additional non-study nutritional supplements including vitamin/mineral supplements, micronutrient fortified beverages, oral nutritional supplements other than the study product during the study intervention period.
  • Child's Legal Guardian (LG) or parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
  • Child's Legal Guardian (LG) or parent(s) is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
  • Child's Legal Guardian (LG) or parent(s)is not planning to relocate during the study period

You may not qualify if:

  • Child has been diagnosed with Lactose Intolerance \& Galactosemia according to medical records or Legal Guardian (LG) /parent report.
  • Child has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or Legal Guardian (LG)/parent report.
  • Child has a current acute or chronic infection including respiratory infection, diarrhea, acute or chronic, Hepatitis B or C, HIV infection or tuberculosis according to medical records or Legal Guardian (LG)/parent report.
  • Child has been diagnosed with presence of severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records or Legal Guardian (LG)/parent report.
  • Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or Legal Guardian (LG) /parent report.
  • Child has been diagnosed with hormonal or metabolic disorders according to medical records or Legal Guardian (LG) /parent report.
  • Child has been diagnosed with congenital disease or genetic disorders such as atrial or ventricular wall defects, or Down's syndrome according to medical records or Legal Guardian (LG) /parent report.
  • Child has been diagnosed with infantile anorexia nervosa according to medical records or Legal Guardian (LG) /parent report.
  • Child has been diagnosed with a developmental disability, including physical disorders such as cerebral palsy, or developmental delay according to medical records or Legal Guardian (LG) /parent report.
  • Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or Legal Guardian (LG) /parent report.
  • Child has a clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Praveen Cardiac Centre

Vijayawada, Andhra Pradesh, 520002, India

Location

St. Theresa's Hospital

Hyderabad, Erragadda, Sanath Nagar, 500018, India

Location

Sangini Hospital

Ahmedabad, Gujarat, 380006, India

Location

JSS Medical College & Hospital

Mysore, Karnataka, 570004, India

Location

Jehangir Clinical Development Centre, Jehangir Hospital

Pune, Maharashtra, 411001, India

Location

Medipoint Hospitals

Pune, Maharashtra, 411007, India

Location

Noble Hospital

Pune, Maharashtra, 411013, India

Location

Sterling Multispeciality Hospital

Pune, Maharashtra, 411044, India

Location

Kanchi Kamakoti Child Trust Hospital

Chennai, Tamil Nadu, 600034, India

Location

Ajanta Research Centre, Ajanta Hospital & IVF Centre

Lucknow, Uttar Pradesh, 226005, India

Location

Institute of Child Health

Kolkata, West Bengal, 700 017, India

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Irfan Shaikh, M.D.

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 14, 2015

Study Start

June 21, 2016

Primary Completion

February 17, 2017

Study Completion

August 1, 2017

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(11)