| CTRI Number |
CTRI/2015/10/006330 [Registered on: 29/10/2015] Trial Registered Prospectively |
| Last Modified On: |
13/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutraceutical] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Oral Nutrition Supplementation study in childrens. |
|
Scientific Title of Study
|
A study of an oral nutritional supplementation in picky eating children |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DA11 Version 1 dated 06 July 2015 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
DrIrfan Shaikh |
| Designation |
Head Pediatric Nutrition Scientific & Medical Affairs |
| Affiliation |
Abbott Nutrition International India |
| Address |
Abbott Healthcare Pvt Ltd
8th Floor Hallmark Plaza
Sant Dyaneshwar Marg Near Gurunanak Hospital Bandra East Mumbai
Maharastra India
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
02267566035 |
| Fax |
|
| Email |
irfan.shaikh@abbott.com |
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Details of Contact Person
Public Query
|
| Name |
ManojMPrabhu |
| Designation |
Manager Clinical Research & Pharmacovigilance |
| Affiliation |
Abbott Nutrition International India |
| Address |
Abbott Healthcare Pvt Ltd
8th Floor Hallmark Plaza
Sant Dyaneshwar Marg Near Gurunanak Hospital Bandra East Mumbai
Maharastra India
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
02267566333 |
| Fax |
|
| Email |
manoj.prabhu@abbott.com |
|
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Source of Monetary or Material Support
|
| Abbott Nutrition
Abbott Healthcare Pvt Ltd
8th Floor, Hallmark Plaza, Sant Dyaneshwar Marg,
Bandra (E)
Mumbai - 400051
India |
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Primary Sponsor
|
| Name |
Abbott Nutrition International India |
| Address |
Abbott Healthcare Pvt. Ltd
11th Floor, Hallmark Plaza, Sant Dyaneshwar Marg,
Bandra (East), Mumbai 400 051
Maharastra, India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
|
| Name |
Address |
| Abbott Nutrition Research and Development |
20 Biopolis Way
#09-01/02 Centros Building
Singapore 138668
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrApurba Gosh |
Institute of Child Health |
Head Department of Paediatrics
11 Dr.Biresh Guha Street Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9830052887
apurbaghosh@yahoo.com |
| DrAnuradhaVKhadilkar |
Jehangir Hospital |
Head Department of Pediatrics
Jehangir Clinical Development Centre,
32, Sassoon Road, Near Pune Station, Pune,
Maharashtra 411001
Pune
MAHARASHTRA |
020-67268800
anuradhavkhadilkar@gmail.com |
| Dr M D Ravi |
JSS Hospital |
Head Department of Pediatrics
Mahathma Gandhi Road, Mysuru,
Karnataka 570004
Mysore
KARNATAKA |
0821-2335555
ravimdped@yahoo.co.in |
| DrPrahalad DPote |
Noble Hospital |
Head Department of Paediatrics
153, Magarpatta City Road, Hadapsar
Pune
MAHARASHTRA
Mumbai
MAHARASHTRA |
9673007958
drpdpote@gmail.com |
| DrPAnil Kumar |
Praveen Cardiac Centre |
Head Department of Pediatrics
Moghalrajpuram Madhu Garden bus stop No.5 bus route Vijayawada
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH |
9848527270
bioexperts21@gmail.com |
| DrAtish Shah |
Sangini Hospital |
Head Department of Paediatrics Sangini Complex, Parimal Crossing
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
07926426360
drtapansah@gmail.com |
| DrBala Kishore |
St. Theresa’s Hospital |
Head Department of Paediatrics Erragatta,Sanath Nagar
Hyderabad
Telengana
Hyderabad
ANDHRA PRADESH |
9949046236
baki2004@gmail.com |
| DrSandipShinde |
Sterling Multispeciality Hospital |
Consultant Department of Pediatrics
Vitthal Rakhumai Rd, Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad,
Maharashtra 411044
Pune
MAHARASHTRA |
9822075706
sandip.shinde@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee Institute of Child Health |
Submittted/Under Review |
| Ethics Committee Jehangir Hospital |
Submittted/Under Review |
| Ethics Committee St. Theresa’s Hospital |
Submittted/Under Review |
| Ethics Committee Sterling Multispeciality Hospital |
Approved |
| Institutional Ethics Committee - Praveen Cardiac Centre |
Approved |
| Institutional Ethics Committee JSS Hospital |
Submittted/Under Review |
| Noble Hospital Institutional Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Childrens 24 months and ≤ 48 months of age with weight-for-height between 3rd – 15th percentiles according to current WHO Growth Charts , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dietary counseling |
Standard nutritional dietary chart
No study products, only nutritional counselling. |
| Comparator Agent |
Oral nutritional supplement and dietary counseling |
Oral nutritional supplement and dietary counseling. (List No- P968/Z0)
Based on habitual milk drinking habit dosing will be decided-
Dosage will be Maximum Two / Minimum One - 224 mL oral serving of supplement per day for period of 90 days |
| Intervention |
Oral Nutritional supplement with dietary couseling |
Oral nutritional supplement and dietary counseling.
(List No S691/Z0)
Based on habitual milk drinking habit dosing will be decided-
Dosage will be Maximum Two / Minimum One - 224 mL oral serving of supplement per day for period of 90 days |
|
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Inclusion Criteria
|
| Age From |
24.00 Month(s) |
| Age To |
48.00 Month(s) |
| Gender |
Both |
| Details |
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
a.eats only a limited number of foods
b.is unwilling to try new foods
c.refuses to eat vegetables and/or foods from other food groups
d.shows strong food likes and dislikes
e.has behaviors that disrupt mealtime
5)Child is a habitual milk drinker at least 1 glass (approx. 200ml) of milk daily.
6)Child is able to consume foods and beverages orally.
7)Child’s 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 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 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 LG or parent(s)is not planning to relocate during the study period
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| ExclusionCriteria |
| Details |
1)Child has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or 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 LG/parent report.
3)Child has a current acute or chronic infection including but not restricted to respiratory infection, diarrhea, Hepatitis B or C, HIV infection or tuberculosis according to medical records or LG/parent report based on the clinician’s judgment.
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 LG/parent report.
5)Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or LG/parent report.
6)Child has been diagnosed with hormonal or metabolic disorders according to medical records or 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 LG/parent report.
8)Child has been diagnosed with infantile anorexia nervosa according to medical records or 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 LG/parent report.
10)Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or 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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in WHO weight-for-height percentile from Day 1 to Day 90 |
Change in WHO weight-for-height percentile from Day 1 to Day 90 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
–Change in weight-for-height WHO z-score.
–Change in weight-for-age WHO z-score and percentile.
–Change in height-for-age WHO z-score and percentile.
–Change in BMI-for-age WHO z-score and percentile.
–Change in MUAC-for-age WHO z-score and percentile.
–Average energy macronutrients(Carbohydrates, Fats, & Proteins) and micronutrients consumption via 24 hr dietary recall.
–Change in appetite score.
–Palatability scores for the oral nutritional supplements.
|
Day 1 to Day 90 |
|
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Target Sample Size
|
Total Sample Size="321"
Sample Size from India="321"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
16/11/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
On completion of the study, the results will be published in the journal (national / international). |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
When the rapidly growing child consumes a limited
quantity and/or variety of foods, there may be significant health consequences.Periods of variable duration characterized by poor appetite, inappropriate
foods for age and/or food refusal are observed in healthy children. Eating
problems in children are common concerns of parents and the severity of these
findings vary widely, from failure to gain weight and height to loss of body
weight. “Picky eating†is a relatively common problem during childhood ranging
from 8% to 50% of children in different published studies.It
is characterized by the toddler or child eating a limited amount of food,
restricting intake particularly of vegetables, being unwilling to try new
foods, and having strong food preferences often leading parents to provide
their child a meal different from the rest of the family. Picky
eaters consume inappropriate quantities of total fats, energy and proteins than
children never reporting picky eating behaviour,
and this can predispose the child to nutritional deficiencies. If
the poor feeding behavior is severe enough to cause growth faltering, long term
growth and development can be negatively affected.It can also
lead to increased susceptibility to infections. Children who are unable to
maintain adequate energy and nutrient intake require modifications in their
feeding habits and oral nutritional supplements may be indicated and effective.
Food and nutrition programs may help to achieve the goal of providing
safe and healthy nutrition to children at risk
Nutritional supplementation may prove beneficial for
proper growth and development in pediatric patients. The goal of
the present study is to compare the efficacy and safety of two pediatric oral
nutritional supplements along with dietary counseling vs dietary counseling
alone on the growth of preschool children in India.
Study will be published in the journal (national / international) after completion of the study. |