| CTRI Number |
CTRI/2023/09/057950 [Registered on: 22/09/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of vitamin B12 supplementation on anthropometric indices in children with severe acute malnutrition (SAM) aged 1 month to 60 month in a nutritional rehabilitation center - a randomized control trial |
|
Scientific Title of Study
|
A Randomized Control Double Blind Parallel group without Placebo Clinical Trial to look the antropometric outcome of Vitamin B12 supplementation in children with severe acute malnutrition(SAM) aged b1 month to 60 months in Nutritional Rehabilitation Center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhartendu Krishna Pathak |
| Designation |
Junior Resident |
| Affiliation |
Department of Pediatrics, Sarojini Naidu Children Hospital, Moti lal Nehru Medical College Allahabad |
| Address |
Department of Pediatrics,Sarojini Naidu Children Hospital,Church Lane,Allahabad
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
7905674638 |
| Fax |
|
| Email |
bkpathak06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Maurya |
| Designation |
Professor |
| Affiliation |
Department of Pediatrics,Sarojini Naidu Children Hospital, Allahabad |
| Address |
Room No 3,Department of Pediatrics,Sarojini Naidu Children Hospital,Church Lane, Allahabad
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
9335982127 |
| Fax |
|
| Email |
drmanisha99@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Maurya |
| Designation |
Professor |
| Affiliation |
Department of Pediatrics,Sarojini Naidu Children Hospital, Allahabad |
| Address |
Room No 3,Department of Pediatrics,Sarojini Naidu Children Hospital,Church Lane, Allahabad
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
9335982127 |
| Fax |
|
| Email |
drmanisha99@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics,Moti Lal Nehru Medical College
Allahabad |
|
|
Primary Sponsor
|
| Name |
Moti Lal Nehru Medical College Allahabad |
| Address |
Department of Pediatrics, Moti Lal Nehru College, Allahabad |
| Type of Sponsor |
Government 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 Bhartendu Krishna Pathak |
Moti Lal Nehru Medical College, Allahabad |
Department of Pediatrics,Sarojini Naidu Children Hospital
Allahabad
Allahabad
UTTAR PRADESH |
7905674638
bkpathak06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Moti Lal Nehru Medical College and associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SAM suppelements |
Vitamin A 50000 unit to 2 lakh unit according to age for 1 day,
Folic acid 1 mg/day for 14 days,
Zinc 2mg/kg/day for 14 days,
Iron 3mg/kg/day for 1 month,
Magnesium 0.4 mmol/kg/day for 14 days,
Potassium 3 meq/kg/day for 14 days,
Copper 0.3 mg/kg/day for 14 days
|
| Intervention |
Vitamin B12 and SAM supplements |
Vitamin B12:500 microgram/day for 6 weeks,
Vitamin A 50000 unit to 2 lakh unit according to age for 1day,
Folic acid 1 mg/day for 14 days,
Zinc 2mg/kg/day for 14 days,
Iron 3mg/kg/day for 1 month,
Magnesium 0.4 mmol/kg/day for 14 days,
Potassium 3 meq/kg/day for 14 days,
Copper 0.3 mg/kg/day for 14 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
60.00 Month(s) |
| Gender |
Both |
| Details |
1.Parents or guardians willing to give written informed consent
2.Age group of 1 month to 60 month children with severe acute malnutrition(SAM)
3.SAM will be defined as : Mid upper arm circumference (MUAC) <11.5 cm and/or weight for height/length <-3 standard deviation and/or bilateral pitting edema
|
|
| ExclusionCriteria |
| Details |
1. All children with non-nutritional anaemia (malignancy,haemolytic anaemia and aplastic anaemia)
2. Children diagnosed to have chronic liver disease, chronic kidney disease, GIT disorder(inflammatory bowel disorders),heart disease,infantile tremor syndrome
3. Children with unstable viatals |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in anthropometric parameters ( weight and height) after vitamin B12 supplementation |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Document changes in Hb levels and MCV levels
2.Describe the prevalence of anemia in enrolled patients
3.Describe percentage of different types of anemia
4.Describe the final outcome of enrolled patients
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
03/10/2023 |
| 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)
|
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
|
Vitamin B12 defficiency is commonly associated in children with severe acute malnutrition and is not used as routine supplements according to WHO guidelines of management of severe acute malnutrition in facility.Vitamin B12 and folate deficiency leads to megaloblastic anemia, poor growth and increased infections.We aim to look for the effect of vitamin B12 supplementation of anthropometric indices and improvement of anemia in children with severe acute malnutrition |