| CTRI Number |
CTRI/2024/03/063843 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
What is the impact of Bovine colostrum on height of children? |
|
Scientific Title of Study
|
Effectiveness of Bovine colostrum on stunting among children aged 9 months to 3 years in Urban slum areas of Belagavi : A Randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ahilam Ameer Ali Sayed |
| Designation |
Student |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, KAHER |
| Address |
Second floor, Department of Public Health, Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, KAHER, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09986567747 |
| Fax |
|
| Email |
ahilams6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr Mubashir Angolkar |
| Designation |
Doctor, Professor and Head Department of Public Health |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, KAHER |
| Address |
Second floor, Department of Public Health, Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, KAHER, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9886983624 |
| Fax |
|
| Email |
drmubi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof. Dr Mubashir Angolkar |
| Designation |
Doctor, Professor and Head Department of Public Health |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, KAHER |
| Address |
Second floor, Department of Public Health, Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, KAHER, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9886983624 |
| Fax |
|
| Email |
drmubi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLEKAHER |
| Address |
KLE Academy of Higher Education and Research, Belagavi |
| Type of Sponsor |
Private medical college |
|
|
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 Mubashir Angolkar |
Jawaharlal Nehru Medical College, KLE University |
Second floor, Department of Public Health, Jawaharlal Nehru Medical College, KLE University Campus, Nehru Nagar, KAHER, Belagavi
Belgaum
KARNATAKA |
9886983624
drmubi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Growth status |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bovine Colostrum |
Bovine Colostrum will be given to children among age group 9 months to 3 years for 3 months |
| Comparator Agent |
Milk Powder |
Milk Powder will be given to children among age group from 9 months to 3 years for 3 months |
|
|
Inclusion Criteria
|
| Age From |
9.00 Month(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy children from age 9 months to 3 years residing in slum areas.
2.Written informed consent from parents/guardians of the participating children.
3.Children who are permanent resident.
|
|
| ExclusionCriteria |
| Details |
Children with any medical conditions:
1. Any genetic disorder
2. Any chronic infection like eg. HIV, Tuberculosis
3. Any chronic systemic disease
4. Any congenital heart disease
5.Any recurrent diarrhoea or respiratory illness
6. Severe anemia
7. Severe malnutrition
8. Children intolerant to milk products
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of Bovine colostrum on stunting among children aged 9 months to 3 years. |
Baseline and study end |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of Bovine colostrum on stunting among children aged 9 months to 3 years. |
Baseline and study end |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
21/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a Randomized Clinical Trial, children from 9 months to 3 years will be recruited. Base line data of socio-demographic, anthropometric measurement, clinical history and dietary questionnaire will be collected. followed by random allocation of children into two arms. the participants and the principal investigator will be blinded by giving the intervention into foiled sachets that will be coded. The intervention will be given for 3 months. after 3 months the study end data of socio-demographic, anthropometric measurement, clinical history and dietary questionnaire will be collected. |