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CTRI Number  CTRI/2019/04/018853 [Registered on: 30/04/2019] Trial Registered Prospectively
Last Modified On: 02/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Micro nutrient fortified food intervention]  
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Evaluation of rice with high nutrient content in school children. 
Scientific Title of Study   Impact evaluation of multi-micro-nutrient fortified rice in improving iron status among school children in rural district of Andhra Pradesh. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandesh Kotte 
Designation  Program Officer 
Affiliation  Tata Trusts 
Address  Tata Trusts, 3rd Floor, ANR Complex, Sri Ramachandra Nagar, Vijayawada.

Krishna
ANDHRA PRADESH
520008
India 
Phone  9035977090  
Fax    
Email  skotte@tatatrusts.org  
 
Details of Contact Person
Scientific Query
 
Name  Sandesh Kotte 
Designation  Program Officer 
Affiliation  Tata Trusts 
Address  Tata Trusts, 3rd Floor, ANR Complex, Sri Ramachandra Nagar, Vijayawada.

Krishna
ANDHRA PRADESH
520008
India 
Phone  9035977090  
Fax    
Email  skotte@tatatrusts.org  
 
Details of Contact Person
Public Query
 
Name  Madhusudhan Rao 
Designation  Lead- Nutrition 
Affiliation  Tata Trusts 
Address  World Trade Center-1, 26th floor Cuffe Parade, Mumbai

Mumbai
MAHARASHTRA
400 005
India 
Phone  9551689397  
Fax    
Email  mrao@tatatrusts.org  
 
Source of Monetary or Material Support  
Tata Trusts World Trade Center-1, 26th floor Cuffe Parade, Mumbai 400 005, India 
 
Primary Sponsor  
Name  Tata Trusts 
Address  World Trade Center-1, 26th floor Cuffe Parade, Mumbai 400 005 
Type of Sponsor  Other [Chritable Trusts] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sandesh Kotte  AP Balayogi Gurukulam (Boys)  M. Showkath Ali, Principal,Dakshanya Campus, Beside RTO office, JKC Road, Adavithakellapadu pin: 522409
Guntur
ANDHRA PRADESH 
9035977090

skotte@tatatrusts.org 
Sandesh Kotte  AP Balayogi Gurukulam (Boys)  K. Kesava Rao, Principal, NSP colony, Darsi Mandal pin: 523247
Prakasam
ANDHRA PRADESH 
9035977090

skotte@tatatrusts.org 
Sandesh Kotte  AP Balayogi Gurukulam (Girls)  R. Padmaja, Principal,Besides Bus stop, Petrol Bunk Road, Amaravathi, Amaravathi Mandal pin:522020
Guntur
ANDHRA PRADESH 
9035977090

skotte@tatatrusts.org 
Sandesh Kotte  APSWR school and Junior College. (Girls)  Smt. Vaasavi, Principal, North Addanki, Adddanki Mandal Pin: 523201
Prakasam
ANDHRA PRADESH 
9035977090

skotte@tatatrusts.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, St Johns Medical College and Hospital  Approved 
Institutional Ethics Committee, St Johns Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Iron deficient/mildly anaemic 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Micro nutrient fortified rice  Hostel meals cooked with micronutrient fortified rice, containing 4.25 mg elemental Fe (ferric pyrophosphate), 0.1μg vitamin B12, 11 μg of Folic acid per, 50 μg of Vitamin A, 0.125mg of Vitamin B1, 1.5mg of Vitamin B3 and 0.2mg of Vitamin B6/ 100 g raw rice, served as two meals on all school days and three meals on all school holidays. 
Comparator Agent  Normal rice grains provided by government under public distribution system  Hostel meals cooked with natural rice grains and served as two meals on all school days and three meals on all school holidays 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children with iron deficiency and mild anaemia 
 
ExclusionCriteria 
Details  Severe anaemia, prescription medication or supplement use; a history of serious illness, under acute medical care within the last 3
months, the presence of any other disease (reported), and food
allergies. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare the change in blood levels of SF,
between the two groups at the end of the
intervention period 
Compare the change in blood levels of SF,
between the two groups at the end of the
intervention period 
 
Secondary Outcome  
Outcome  TimePoints 
Compare change in prevalence of anaemia, iron
deficiency and iron deficiency anaemia between
the two groups at the end of the intervention 
Baseline at the starting of the intervention and
endline after 12 months of intervention 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/05/2019 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details
Modification(s)  
Since the study has been terminated owing to COVID-19 and other reasons, we are not going to take forward this and publish the results.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Tata Trusts in collaboration with Andhra Pradesh State Civil Supplies Corporation Limited (APSCSCL) successfully piloted the usage of fortified rice in ICDS and Mid-day meals programs in West Godavari and Krishna districts.  In this context, Tata Trusts has initiated an efficacy trial to capture the longitudinal impact of fortified rice on school children in Andhra Pradesh. In accordance with that, we have obtained necessary regulatory as well as ethical approvals and rolled out the efficacy study.

 

To this end, we have selected following Andhra Pradesh Social Welfare Residential (APSWR) Schools of Guntur and Prakasam Districts for the efficacy study.

·         Adavithakellapadu (Boys School), Tadikonda (M), Guntur District- Treatment group

·         Amaravati (Girls School), Amaravati (M), Guntur District- Treatment group

·         Darsi (Boys School), Darsi (M), Prakasam District- Control group

·         North Addanki (Girls School), Addanki (M), Prakasam District- Control group

 

Upon Selection of schools, we have initiated baseline assessment in all four schools during July 2019. As part of the assessment, we have conducted multiple medical camps and screened around 490 students and collected blood samples from students to track their CRP, HB levels as required by the study. Based on preliminary reports of baseline assessment, it was observed that around 160 students are suffering from Iron deficiency while 33% of students are anaemic.

  

After conducting the baseline assessment, with the support of Tata Trusts, APSCSCL has provided the fortified rice to treatment group students as per the study plan. In line with this, an intensive monitoring of the mechanism was kept in place to track the consumption patterns of the students during the study period.  

 

As per study timelines, the end-line assessment was planned to conduct in April 2020. But After COVID-19 outbreak and nation-wide lockdown, it was decided to defer the study to April 2021 based on technical inputs from Government and study stakeholders.

However, due to the second wave of corona and the rapid spike in COVID-19 cases across the state, the Director of School Education, Andhra Pradesh has announced to classes 1 to 9th that all schools shall be closed under all managements with immediate effect (G.O. RT No. 11 dated 19.04.2021).  Since our study population lies in the above group, it is not feasible to continue further owing to student unavailability to participate in the end line assessment.  

 

In view of this and after detailed consultations with relevant stakeholders including technical partner-  St Johns research institute, it was advised to dismiss the end line assessment study thereby entirely terminate the efficacy trial of rice fortification with immediate effect. The termination of the study will be informed to children and Management of respective schools as per study protocols.

 
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