| 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
|
|
|
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
|
|
|
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. |