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CompletedNCT02523027Updated Mar 14, 2018

Oral Nutritional Supplementation in Picky Eating Children

A Phase 2/3 interventional study of Oral nutritional supplement (List No S691/Z0) and Oral nutritional supplement in Children - Malnutrition, sponsored by Abbott Nutrition. Completed at 11 sites in India. Open to participants aged 2 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-14.

Sponsored by Abbott Nutrition · Phase 2/3, Interventional, and Supportive care

Phase
Phase 2/3
Study type
Interventional
Enrollment
321
Allocation
Randomized
Ages
2 Years to 4 Years
Sex
All
01

Study 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.

Read the detailed description

Study Objective:

To 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.

Number of Subjects / Length of Participation:

Approximately 321 subjects (107 subjects per group) will be enrolled from estimated 8-10 study centers to obtain at least 255 evaluable subjects (85 subjects per group), assuming 20% attrition rate. Expected total duration for the study is approximately 12 months.

Study Design :

  • Prospective, randomized, double blinded study, with two parallel treatment groups and an open-labeled control group multicenter clinical study Eligible subjects will be randomized into three groups
  • Experimental Group 1: Oral nutritional supplement and dietary counseling. (List No S691/Z0)
  • Experimental Group 2: Oral nutritional supplement and dietary counseling. (List No- P968/Z0)
  • Control Group: Dietary counseling.
02

Conditions studied

  • Children - Malnutrition

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 321 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 4 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Child is > 24 months and ≤ 48 months of age at visit 1.
  2. Child of either gender (Male and Female).
  3. Child has a weight-for-height between 3rd - 15th percentiles according to current WHO Growth Charts at visit 1. (WHO Growth Chart 2007)
  4. 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
  5. Child is a habitual milk drinker at least 1 glass (approximately 200mL) of milk daily.
  6. Child is able to consume foods and beverages orally.
  7. 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.
  8. 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.
  9. 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.
  10. Child's Legal Guardian (LG) or parent(s)is not planning to relocate during the study period

Exclusion criteria

Exclusion Criteria:

  1. Child has been diagnosed with Lactose Intolerance \& Galactosemia according to medical records or Legal Guardian (LG) /parent report.
  2. 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.
  3. 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.
  4. 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.
  5. Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or Legal Guardian (LG) /parent report.
  6. Child has been diagnosed with hormonal or metabolic disorders according to medical records or Legal Guardian (LG) /parent report.
  7. 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.
  8. Child has been diagnosed with infantile anorexia nervosa according to medical records or Legal Guardian (LG) /parent report.
  9. 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.
  10. Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or Legal Guardian (LG) /parent report.
  11. Child has a clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
  12. Child has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
321 participants (actual)

Study arms

  • Experimental
    Experimental Group 1:

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

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

  • Experimental
    Experimental Group 2

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

    Dietary Supplement: Oral nutritional supplement · Other: Dietary Counselling

  • No intervention
    Control Group

    Dietary Counselling only.

Interventions

  • Dietary supplementOral nutritional supplement (List No S691/Z0)

    (List No S691/Z0)

  • Dietary supplementOral nutritional supplement

    (List No- P968/Z0)

  • OtherDietary Counselling

    Regular dietary counseling conducted by a trained hospital dietitian.

06

What researchers measure

Primary outcomes

  1. Change in WHO weight-for-height percentile

    Time frame: Day 1 to Day 90

Secondary outcomes

  1. Change in weight-for-height WHO z-score

    Time frame: Day 1 to Day 90

  2. Change in weight-for-age WHO z-score and percentile

    Time frame: Day 1 to Day 90

  3. Change in height-for-age WHO z-score and percentile

    Time frame: Day 1 to Day 90

  4. Change in BMI-for-age WHO z-score and percentile

    Time frame: Day 1 to Day 90

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

    Time frame: Day 1 to Day 90

  6. Average energy macronutrients (Carbohydrates, Fats, & Proteins) and micronutrients consumption via 24 hr dietary recall

    Time frame: Days 1, 7, 30, 60 and 90

  7. Change in appetite score

    Time frame: Days 1, 7, 30, 60 and 90

  8. Palatability scores for the oral nutritional supplements

    Time frame: Days 7, 30, 60 and 90

  9. Change in weight-for-height WHO z-score and percentile

    Time frame: Day 1 to Day 90

  10. Average energy macronutrients (Carbohydrates, Fats, & Proteins) and micronutrients consumption via 24 hr dietary recall

    Time frame: Day 1, 7, 30, 60 and 90

07

Study locations

11 sites
  • Praveen Cardiac Centre
    Vijayawada, Andhra Pradesh 520002, India
  • St. Theresa's Hospital
    Hyderabad, Erragadda, Sanath Nagar 500018, India
  • Sangini Hospital
    Ahmedabad, Gujarat 380006, India
  • JSS Medical College & Hospital
    Mysore, Karnataka 570004, India
  • Jehangir Clinical Development Centre, Jehangir Hospital
    Pune, Maharashtra 411001, India
  • Medipoint Hospitals
    Pune, Maharashtra 411007, India
  • Noble Hospital
    Pune, Maharashtra 411013, India
  • Sterling Multispeciality Hospital
    Pune, Maharashtra 411044, India
  • Kanchi Kamakoti Child Trust Hospital
    Chennai, Tamil Nadu 600034, India
  • Ajanta Research Centre, Ajanta Hospital & IVF Centre
    Lucknow, Uttar Pradesh 226005, India
  • Institute of Child Health
    Kolkata, West Bengal 700 017, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02523027
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Aug 14, 2015
Start date
Jun 21, 2016
Primary completion
Feb 17, 2017
Completion
Aug 2017
Last update
Mar 14, 2018

Study contacts

Irfan Shaikh, M.D.
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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