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Children - MalnutritionPhase 2/3NCT02523027

Oral Nutritional Supplementation in Picky Eating Children

A Phase 2/3 study testing Oral nutritional supplement (List No S691/Z0), Oral nutritional supplement and Dietary Counselling in people with Children - Malnutrition, run by Abbott Nutrition at 11 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 2 to 4 yearsHealthy volunteers can take part
Conditions the study is for
Children - Malnutrition
What is being tested?
Oral nutritional supplement (List No S691/Z0), Oral nutritional supplement and Dietary Counselling
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
11 sitesIndia
Study dates
21 Jun 2016to Aug 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 4 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.
  • Child has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

India11 sites

  • Sangini Hospital

    Ahmedabad, Gujarat, 380006

  • Kanchi Kamakoti Child Trust Hospital

    Chennai, Tamil Nadu, 600034

  • St. Theresa's Hospital

    Hyderabad, Erragadda, Sanath Nagar, 500018

  • Institute of Child Health

    Kolkata, West Bengal, 700 017

  • Ajanta Research Centre, Ajanta Hospital & IVF Centre

    Lucknow, Uttar Pradesh, 226005

  • JSS Medical College & Hospital

    Mysore, Karnataka, 570004

  • Jehangir Clinical Development Centre, Jehangir Hospital

    Pune, Maharashtra, 411001

  • Medipoint Hospitals

    Pune, Maharashtra, 411007

  • Noble Hospital

    Pune, Maharashtra, 411013

  • Sterling Multispeciality Hospital

    Pune, Maharashtra, 411044

  • Praveen Cardiac Centre

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

About this study

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.
Being tested
Oral nutritional supplement (List No S691/Z0), Oral nutritional supplement, Dietary Counselling
Medical subject headings
Child Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    (List No S691/Z0)

  • Oral nutritional supplementDietary supplement

    (List No- P968/Z0)

  • Dietary CounsellingOther

    Regular dietary counseling conducted by a trained hospital dietitian.

Study groups in NCT02523027
Study groupRoleWhat they receive
Experimental Group 1:ExperimentalOral nutritional supplement (List No S691/Z0) and dietary counseling
Receives: Dietary Supplement: Oral nutritional supplement (List No S691/Z0); Other: Dietary Counselling
Experimental Group 2ExperimentalOral nutritional supplement (List No- P968/Z0) and dietary counseling.
Receives: Dietary Supplement: Oral nutritional supplement; Other: Dietary Counselling
Control GroupNo interventionDietary Counselling only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in WHO weight-for-height percentile

    Measured: Day 1 to Day 90

Secondary outcomes (10)

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

    Measured: Day 1 to Day 90

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

    Measured: Day 1 to Day 90

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

    Measured: Day 1 to Day 90

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

    Measured: Day 1 to Day 90

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

    Measured: Day 1 to Day 90

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

    Measured: Days 1, 7, 30, 60 and 90

  7. Change in appetite score

    Measured: Days 1, 7, 30, 60 and 90

  8. Palatability scores for the oral nutritional supplements

    Measured: Days 7, 30, 60 and 90

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

    Measured: Day 1 to Day 90

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

    Measured: Day 1, 7, 30, 60 and 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2015 (estimated)
  2. Study start21 Jun 2016
  3. Primary completion17 Feb 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02523027
Sponsor's protocol ID
DA11
Status last verified
Mar 2018
First submitted
12 Aug 2015
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oral nutritional supplement (List No S691/Z0), Oral nutritional supplement and Dietary Counselling in people with Children - Malnutrition, run by Abbott Nutrition at 11 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in WHO weight-for-height percentile (time frame: Day 1 to Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02523027.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.

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