| CTRI Number |
CTRI/2024/08/071861 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Impact of multiple micronutrients fortified Oral Nutrition Supplements on physical growth, strength and cognition in School Aged Children. |
Scientific Title of Study
Modification(s)
|
Impact of Multiple Micronutrients Fortified Oral Nutrition Supplements on Physical Growth, Muscle Parameters, Strength, and Cognitive Development in School Aged Children (6-16 years): Randomized Controlled Study |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NUN-HFD-009/24, V: 5.0, Dated:28Oct2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuradha Khadilkar |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre Pvt Ltd,
Jehangir Hospital Premises,
32 Sasson Road,
Pune- 411001,
Maharashtra, India
Pune
MAHARASHTRA
411001
India |
| Phone |
9850244305 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Somesh Bolegave |
| Designation |
Medical Expert |
| Affiliation |
Siro Clintech Private Limited |
| Address |
Siro Clintech Private Limited,
Asmaco House, 3rd floor, Plot No. B-41, Road No. 27, Wagle Industrial Estate, opposite to ITI, Thane West, Mumbai - 400604
Thane
MAHARASHTRA
400604
India |
| Phone |
09969205149 |
| Fax |
02261088045 |
| Email |
somesh.bolegave@siroclinpharm.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Somesh Bolegave |
| Designation |
Medical Expert |
| Affiliation |
Siro Clintech Private Limited |
| Address |
Siro Clintech Private Limited
Asmaco House, 3rd floor, Plot No. B-41, Road No. 27, Wagle Industrial Estate, opposite to ITI, Thane West, Mumbai - 400604
Thane
MAHARASHTRA
400604
India |
| Phone |
09969205149 |
| Fax |
02261088045 |
| Email |
somesh.bolegave@siroclinpharm.com |
|
|
Source of Monetary or Material Support
|
| Hindustan Unilever Limited |
|
|
Primary Sponsor
|
| Name |
Hindustan Unilever Limited |
| Address |
Unilever House, B D Sawant Marg Chakala,
Andheri (East), Mumbai 400099, Maharashtra
|
| Type of Sponsor |
Other [Fast moving consumer goods (FMCG)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuradha Khadilkar |
Jehangir Clinical Development Centre Pvt Ltd |
Jehangir Hospital Premises,
32 Sasson Road,Pin- 411001,India
Pune
MAHARASHTRA |
9850244305
anuradhavkhadilkar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Cow’s milk |
To receive 150 ml cow’s milk twice a day for 6 months |
| Comparator Agent |
Dietary counselling |
Dietary counselling for 6 months |
| Intervention |
Oral Nutritional supplement ONS 1 |
The ONS 1 is micronutrient fortified powder to be consumed as a nutritional supplement added to milk. There are no changes in the macronutrients composition of ONS 1 as only micronutrients such as Vit A, B, C, D, Iron, Calcium, Zinc, Iodine, copper, magnesium phosphorous, selenium etc have been aligned to 1 RDA compliant in ONS 1.
GI of the reconstituted drinks is low GI of 55 (Khanna et al 2023)
It has a unique manufacturing process which uses natural enzymes of cereal grains to generate complex carbohydrates which are beneficial and have prebiotic benefits.
For ONS 1, daily serve is 54 g of powder in 300 ml milk (27 g in 150 ml milk twice daily) (as per clinically studied recommendation) (1-5).
As consumed in milk, the drinks deliver 422 Kcal of energy (approx.18 percent EAR)
The ONS 1 is aligned to AMDR guidelines and have the macronutrient composition delivering:
15.7 g of protein (approx. 46 percent of RDA) with protein contributing 15 percent of energy
13 g of fat (35 percent of RDA) with fat contributing 28 percent of energy.
57.5 g of carbohydrate (44 percent of RDA) and carbohydrate contributing 54 percent of energy
As a powder, they are designed to be low-fat formulae with 1.1 g of fat per day (54 g). Per daily serve, they deliver 0.9 g saturated fat, negligible trans-fat (0.04 g) and less than 5 mg cholesterol and deliver 243 mg of sodium (15 percent of RDA).
They deliver 26 vitamins and minerals.
|
| Intervention |
Oral Nutritional supplement ONS 2 |
The ONS 2 is micronutrient fortified powder to be consumed as a nutritional supplement added to milk. There are no changes in the macronutrients composition of ONS 2. GI of the reconstituted drinks is low GI of 55 (Khanna et al 2023) It has a unique manufacturing process which uses natural enzymes of cereal grains to generate complex carbohydrates which are beneficial and have prebiotic benefits. For ONS 2, daily serve is 54 g of powder in 300 ml milk (27 g in 150 ml milk twice daily) (as per clinically studied recommendation) (1-5). As consumed in milk, the drinks deliver 422 Kcal of energy (approx.18 percent EAR) The ONS 2 are aligned to AMDR guidelines and have the macronutrient composition delivering: 15.7 g of protein (approx. 46 percent of RDA) with protein contributing 15 percent of energy 13 g of fat (35 percent of RDA) with fat contributing 28 percent of energy. 57.5 g of carbohydrate (44 percent of RDA) and carbohydrate contributing 54 percent of energy As a powder, they are designed to be low-fat formulae with 1.1 g of fat per day (54 g). Per daily serve, they deliver 0.9 g saturated fat, negligible trans-fat (0.04 g) and less than 5 mg cholesterol and deliver 243 mg of sodium (15 percent of RDA). They deliver 26 vitamins and minerals. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Normal and mildly malnourished children with BMI-for-age percentiles [between 3rd to 25th percentile (-1.881) to (-0.674) z-score] by calculating as per WHO 5-19 years Growth Reference will be included
2.Screening for anemia will be done to include all children with hemoglobin ≥8 mg/dl
3.Children ≥ 6 years to ≤ 16 years will be included. (25-30 children per age). Stratification of pubertal (10 -15+ years) and prepubertal (6-9+ years) will be done later. Both boys and girls will be included
4.Children should not be lactose intolerant /have lactose sensitivity and be comfortable to have milk daily.
[0 – (-1 SD) are normal children; (−1 to −1.9 SD) is defined as mild malnutrition; [−2 to −2.9 SD) is defined as moderate malnutrition; [(≥ −3) is defined as severe malnutrition].
[mild anaemia defined as 11 – 11.49 and 11 – 11.99 mg/dl for children 5-11 years and 12-14 years respectively; moderate anaemia defined as 8 - 10.99 mg/dl for children 5-11 years and 12-14 years respectively] |
|
| ExclusionCriteria |
| Details |
Children will be excluded at the time of screening, if they had been diagnosed or were known to:
1.be lactose intolerant and galactosaemic
2.be allergic or intolerant to wheat / any other cereal
3.have a current acute or chronic infection including but not restricted to respiratory infection, diarrhoea, Hepatitis B or C, HIV infection or tuberculosis.
4.have severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis; have a diagnosis of neoplastic, renal, hepatic or cardiovascular disease, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, or Down’s syndrome, infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay.
5.diagnosed with disorders of haemoglobin structure, function, or synthesis according to medical records or parent/guardian report, or
6.have been diagnose with ADHD, any form of delayed / impaired cognitive development, delayed developmental milestones, or is on any form of medication for other cognitive conditions.
7.have had a clinically significant nutritional deficiency requiring specific treatment with another similar nutritional supplement (other than the study product) or
8.have any other clinically significant medical condition, which, in the investigator’s opinion, made the child unsuitable for inclusion in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of two high protein-micronutrient fortified drinks on physical growth of school children and adolescents as assessed by BMI-for-age percentiles |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of two high protein micronutrient fortified drinks on school children (6 – 16 years) as assessed by
Anthropometric parameters
1) height-for-age
2) (weight, height, MUAC, waist circumference, Tricep skinfold)
Body composition
3) Bio Impedance Analysis (BIA)
4) DEXA (in a sub sample)
5)bone mineral content (BMC DEXA
6) bone mineral density (BMD) by DEXA.
7) muscle mass by DEXA.
8) hand grip strength by hand dynamometer
9) cognitive function by CANTAB battery of tests |
6 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1200"
Sample Size from India="1200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
05/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a randomized, controlled four-armed study. A total of 1200 mildly malnourished or normal children, both male and female, aged 6-16 years will be randomized into four arms equally to ensure at least n=256 completers in each group (at least n=1024 completers in all). The test groups will receive the high protein micronutrient fortified ONS drinks (ONS 1 and ONS 2) for 6 months along with dietary counselling (DC). Control group 1 will be receiving cow’s milk for 6 months and control group 2 will be receiving only dietary counselling. Counselling sessions will be conducted on Visit 1, Visit 2 and Visit 3. The study groups will be: 1. TEST ARM 1: To receive the new revised 1 RDA compliant micronutrient fortified ONS 1 along with dietary counselling for 6 months. The ONS 1 (27 g) in 150 ml cow’s milk twice a day will be supplemented for 6 months. 2. TEST ARM 2: To receive the existing micronutrient fortified ONS 2 along with dietary counselling for 6 months. The ONS 2 (27 g) in 150 ml cow’s milk twice a day will be supplemented for 6 months. 3. CONTROL ARM 1: To receive 150 ml cow’s milk twice a day for 6 months 4. CONTROL ARM 2: To receive only dietary counselling for 6 months |