| CTRI Number |
CTRI/2019/11/021993 [Registered on: 13/11/2019] Trial Registered Prospectively |
| Last Modified On: |
16/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial of NRL/2019/5PNK to promote growth, health and wellbeing in children. |
|
Scientific Title of Study
|
Randomized control trial to assess the efficacy and safety of NRL/2019/5PNK with
micronutrient fortification to promote growth, health and wellbeing in children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/19-20/008 Ver 1.0 dated 4th September 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidyadhar Kumbhar |
| Designation |
Consultant |
| Affiliation |
Sunad Ayurved |
| Address |
Ground floor, OPD 1, Wolf Colony, Chinchwad- Pune 33
Pune MAHARASHTRA 411033 India |
| Phone |
|
| Fax |
|
| Email |
dr.vidyadhar24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Omkar Kulkarni |
| Designation |
Senior Manager, Research and Development |
| Affiliation |
Netsurf Research Labs Pvt Ltd |
| Address |
107, Plot 2, Laxman Nagar, Baner
Road, Baner, PUNE 411045
(Maharashtra) India.
Pune MAHARASHTRA 411045 India |
| Phone |
|
| Fax |
|
| Email |
omkar.kulkarni@nrl.net.in |
|
Details of Contact Person Public Query
|
| Name |
Ms Priya Khare |
| Designation |
Senior Manager, Research and Development |
| Affiliation |
Netsurf Research Labs Pvt Ltd |
| Address |
107, Plot 2, Laxman Nagar, Baner
Road, Baner, PUNE 411045
(Maharashtra) India.
Pune MAHARASHTRA 411045 India |
| Phone |
|
| Fax |
|
| Email |
priya.khare@netsurfnetwork.com |
|
|
Source of Monetary or Material Support
|
| Netsurf Communications Pvt Ltd, 107, Plot 2, Laxman
Nagar, Baner Road,
Baner, PUNE 411045 (Maharashtra) India. |
|
|
Primary Sponsor
|
| Name |
Netsurf Communications Pvt Ltd |
| Address |
107, Plot 2, Laxman
Nagar, Baner Road,
Baner, PUNE 411045 (Maharashtra) India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vidyadhar Kumbhar |
Sunad Ayurved |
First floor, OPD 1, Wolf colony, Chinchwad, Pune 33 Pune MAHARASHTRA |
9960075536
dr.vidyadhar24@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| College of Ayurved and Research Centre, Akurdi Pune 44 |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health And well being |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Marketed Product |
Protein supplement with micronutrient fortification
10 gm in 150 ml once in morning for 90 days |
| Intervention |
NRL/2019/5PNK |
Protein supplement with micronutrient fortification
10 gm in 150 ml once in morning for 90 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children Aged 06 - 11 years inclusive (both gender)
Consent: Understanding of the study and willingness to participate as evidenced by subject’s
parents and/or legal guardian’s voluntary written informed consent.
Compliance: Understands and is willing, able and likely to comply with all study procedures
and restrictions. |
|
| ExclusionCriteria |
| Details |
Subject has a known allergy or intolerance to the study product or ingredients or is on a
special diet and cannot consume the study product
Subject has a current illness requiring hospitalization
Subject has a gastrointestinal infection and/or acute diarrhea at the time of inclusion in the
study
Subject is currently taking medication that could affect absorption/metabolism of study
product or weight of the child. Exception: Topical/ocular steroids will be permitted during the
study
Subject is diagnosed with recurrent respiratory infections due to cystic fibrosis,
immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital
lung and ciliary abnormalities, an unsuspected foreign body and asthma. (As per history and
documentation in the medical records)
Subject has active tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history and documentation in the medical records) as per discretion of investigation
Subject has a history of diabetes mellitus (as per history and documentation in the medical
records)
Subject has been on antibiotic therapy within the last one month before start of the study
(before study Day 1)
Subject has dysphagia, aspiration risk, and difficulty in swallowing due to acquired /
congenital abnormalities that would hamper oral intake of the study product. (As per history and
documentation in the medical records)
Subject has a clinically significant nutritional deficiency requiring specific treatment with any
other nutritional supplement (not study product) as diagnosed by the investigator. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in weight (WHO z-score)
Change in Anthropometric parameters
Change in Blood biochemical tests - Serum iron, Serum calcium
Questionnaire for evaluation of development and behaviour like- Motor activity, Cognition, memory skills, social skills , Attention and concentration, Over activity and impulsivity, Perception of space and directions, Concepts of time, Perception of visual forms and figures, Passivity/inactivity and Planning/organizing etc
Change in Cardiopulmonary performance
|
From baseline to end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Immunity profile
Change in appetite score
Emotional Quotient Questionnaire
Changes in Liver Function test, Renal Function Test, Blood glucose, HbA1C, Thyroid Function Test, CBC etc.
Change brain derived neuronal factor levels
Adverse events
Assessment of Overall Improvement by parent and investigator
Palatability with dosage compliance
|
From baseline to end of study |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
12/11/2019 |
| 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="0" Months="5" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After Ethics committee’s approval, clinical study will be
registered on CTRI website. Children subjects of age between 06 to 11 years of
both sex (inclusive) attending outpatient departments/consultation department
of study site (s) will be screened for eligibility criteria. On screening
visit, a written informed consent will be obtained from subject’s
guardian/parents for their participation in the study. Subject’s demographic
details will be taken. Subject will undergo clinical examination (general and
systemic examination). Subject’s medical, surgical and treatment history will
be taken. Subject’s current medication if any will be noted in the case record
from (CRF). The subject will be considered for further evaluation as per the
inclusion and exclusion criteria. Subject will be called next day morning on empty
stomach for laboratory testing. Subject’s blood sample will be collected at the
respective study centers for laboratory testing i.e. CBC, ESR, Hb%, Liver
Function Tests, Renal Function test, HbA1c etc. Subject’s Urine Routine will be
done. During screening visit and the entire study duration subjects will be
advised to refrain from antioxidant agents, vitamins, health supplements,
Nutraceuticals, Ayurvedic, Siddha, Unani, herbal /homeopathic medicines. A
screening window of 14 days will be kept, in case if there is delay in
availability of tests reports or in case few tests need to be repeated. Subject
will be called for baseline visit assessment (day 0). On baseline visit,
subject will be recruited in the study if he/she meets all the inclusion criteria.
Subjects will then be randomized to one of the two study groups as per the
computer generated randomization list. Subject’s parent/ guardian will be asked
for occurrence of any adverse event during screening period. Subject will
undergo clinical examination (general and systemic examination). Subject’s
growth- change in weight (WHO z-score), anthropometric parameters and blood
biochemical tests - Serum iron, Serum calcium will be assessed. The
questionnaire for evaluation of development and behavior like- Motor activity,
Cognition, memory, social skills , Attention and concentration, Over activity
and impulsivity, Perception of space and directions, Concepts of time,
Perception of visual forms and figures, Passivity/inactivity and
Planning/organizing etc. and cardiopulmonary performance by VO2, will be
assessed. At baseline visit and at every follow up visit (except last follow up
visit), as per computer generated randomization list, subjects will be provided
with containers each containing 350 gms (300 gms for 30 days + additional 50
gms for use if follow up is delayed maximum up to 5 days) of either ‘Kids
Protein Supplement’ or Standard. Subject will be advised to consume given
supplement in a dose of 10gms in the morning with 150 ml milk for 3 months.
Subject will be advised to continue his concomitant medication other than
antioxidant agents, vitamins, health supplements, Nutraceuticals, Ayurvedic,
Siddha, Unani, herbal /homeopathic medicines etc. The record of concomitant
medication will be kept in the CRF. Product compliance will be assessed by the
investigator on every follow up visit. Subjects who continuously misses dosing
for >3 consecutive days or total missed dose > 9 days during the study
period will be treated as drop outs. Subjects will be allowed to come for
follow up either 5 days prior or after the scheduled follow up visit, provided
subject should continue the given treatment. Subjects will be called at
respective study sites for follow up visits after every month up to 3 months
after the baseline visit. On every follow up visit, Subject will undergo
clinical examination. Subject’s growth- change in weight (WHO z-score),
anthropometric parameters will be assessed. The questionnaire for evaluation of
development and behavior like- Motor activity, Cognition, memory, social skills
, Attention and concentration, Over activity and impulsivity, Perception of
space and directions, Concepts of time, Perception of visual forms and figures,
Passivity/inactivity and Planning/organizing will be assessed. Subject’s
immunity profile no. of recurrent acute Upper Respiratory tract infection
(URTI), no. of sick days per month will be assessed by the presence of any
acute URTI, No. of days required to recover from episode of infection will be
recorded. Subject’s change in appetite score, emotional Quotient Questionnaire
will be assessed. On third follow up visit (i.e. Day 90) subject’s growth-
change in weight (WHO z-score), anthropometric parameters and blood biochemical
tests - Serum iron, Serum calcium will be assessed. The questionnaire for
evaluation of development and behavior like- Motor activity, Cognition, memory,
social skills , Attention and concentration, Over activity and impulsivity,
Perception of space and directions, Concepts of time, Perception of visual
forms and figures, Passivity/inactivity and Planning/organizing etc. and
cardiopulmonary performance by VO2, will be assessed. Subject’s immunity
profile no. of recurrent acute Upper Respiratory tract infection (URTI), no. of
sick days per month will be assessed by the presence of any acute URTI, No. of
days required to recover from episode of infection will be recorded. Subject’s
change in appetite score, emotional Quotient Questionnaire will be assessed.
Global assessment of overall improvement will be done by subject’s parent and
investigator on last follow up visit. Palatability with dosage compliance will
be assessed by the investigator and by subject of test product from baseline to
end of the study. All the subjects will be closely monitored for any adverse
event starting from baseline visit till the end of the study visit. After
completion of 3 months of study treatment, all the subjects will be asked to
stop trial medications and take advice of investigator for further treatment. |