| CTRI Number |
CTRI/2024/12/078745 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to Evaluate the Effects of Nutritional Supplements in Children Aged 2 to 6 Years with Mild to Moderate Acute Malnutrition in the Sub-Urban Regions of India |
|
Scientific Title of Study
|
Effect Of Indigenously Prepared Nutritional Supplement In Children With Mild To Moderate Acute Malnutrition In India Sub-Urban Region - A Prospective Facility-Based Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Dabir |
| Designation |
Principal Investigator |
| Affiliation |
Niramay (NGO) |
| Address |
Niramay (NGO), C/123, Chandranil Housing Society, Near Ramkrishna Math, Sinhagad Road, Pune
Pune MAHARASHTRA 411030 India |
| Phone |
|
| Fax |
|
| Email |
niramay.pune@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pranit Ambulkar |
| Designation |
Assistant General Manager R & D |
| Affiliation |
Netsurf Communication Pvt Ltd. |
| Address |
Netsurf Communication Pvt Ltd., Sr. No. 107, Plot No 2, Laxman Nagar, Baner, Pune
Pune MAHARASHTRA 411045 India |
| Phone |
9785587317 |
| Fax |
|
| Email |
pranit.a@netsurfdirect.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mangesh Shende |
| Designation |
Chief Executive Officer |
| Affiliation |
Akshar Global Clinical Research Private Limited |
| Address |
AKSHAR GLOBAL CLINICAL RESEARCH PVT. LTD.,322, Shreeya Amalga, Avalon Hotel Cross Road, Thaltej, Ahmedabad
Ahmadabad GUJARAT 380054 India |
| Phone |
9978078056 |
| Fax |
|
| Email |
mangesh.shende@agcro.com |
|
|
Source of Monetary or Material Support
|
| Netsurf Communication Pvt Ltd. |
|
|
Primary Sponsor
|
| Name |
Netsurf Communication Pvt Ltd. |
| Address |
Netsurf Communication Pvt Ltd., Sr. No. 107, Plot No 2, Laxman Nagar, Baner, Pune – 411045 |
| 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 Sakshi Dabir |
Niramay (NGO) |
Niramay (NGO)C/123, Chandranil Housing Society, Near Ramkrishna Math, Sinhagad Road, Pune 411030. Pune MAHARASHTRA |
7249887861
niramay.pune@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee-CIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E440||Moderate protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
15 gram Nutritional supplement with 150 ml of milk for 90 days |
15 gram Nutritional supplement with 150 ml of milk in the morning for 90 days |
| Comparator Agent |
150 ml of milk for 90 days |
150 ml of milk in the morning for 90 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
The subjects should follow following inclusion criteria to participate in the study-
1. Children in between 2 -6 years of either sex.
2. Guardian/ parent is willing to provide consent and follow the schedule of the study.
3. Patient evaluated with Grade acute mild to moderate stage of Malnutrition
4. Patients with PEM
|
|
| ExclusionCriteria |
| Details |
The subjects should not present any of the following exclusion criteria-
1. Children who have Systemic diseases like Tuberculosis, Diabetes,
any other grave infectious illness requiring active management.
2. PEM due to Gross congenital problems, Malignancies, Mal-absorption syndrome or inborn errors of metabolism will be excluded.
3. Children evaluated with other grades of PEM, i.e. normal, grade 3.
4. and severe acute malnutrition
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objectives of the study will be to evaluate-
• Growth- Change in weight and height (WHO z-score)
• Improvement-Change in mid arm circumference |
Screening Visit (up to -7 days) to Visit 3 (Day 90 ± 5 days)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objectives of the study will be to evaluate-
• No. of days required to recover from episode of infection
• Eating Behavior Questionnaire (CEBQ)
• Emotional Quotient Questionnaire (EQQ)
• Assessment of Overall Improvement by parent & investigator
|
Screening Visit (up to -7 days) to Visit 3 (Day 90 ± 5 days) |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
01/01/2025 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Screening of kids of age between 2 to 6 visiting around 300 Anganwadi in sub-urban area in north Pune will be screened for acute malnutrition with help of NGO ‘Niramay’ and Anganwadi workers. Those falling under acute mild and moderate malnutrition, based on the consent given by the parents will be enrolled for trial group. Those not willing to consume trial supplement, but willing to enroll for health evaluation and guidance regarding home based dietary modification will be enrolled for control group for comparison. 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 for below visit schedule: · Screening Visit (up to -7 days) · Baseline Visit (Day 1) · Visit 1 (Day 30 ± 5 days) · Visit 2 (Day 60 ± 5 days) · Visit 3 (Day 90 ± 5 days) Subject will undergo clinical examination (general and systemic examination). Subject’s anthropometric parameters along with Growth- Change in weight and height (WHO z-score) and Improvement-Change in mid arm circumference at screening and 90 days will be assessed. No. of days required to recover from episode of infection will be recorded. Subject’s change in appetite score, Child Eating Behaviour Questionnaire, 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/Serious Adverse Event starting from baseline visit till the end of the study visit. After completion of 90 days of study treatment, all the subjects will be asked to stop trial product/medications and take advice of investigator for further treatment. |