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Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 12:51:42 GMT)

CTRI Number CTRI/2013/04/003604 [Registered on: 30/04/2013] - Trial Registered Retrospectively Last Modified On 30/04/2013 Post Graduate Thesis No Type of Trial Interventional Type of Study Process of Care Changes Nutraceutical Other (Specify) [Nutritional, micro nutional and Iron and folic acid] Study Design Non-randomized, Active Controlled Trial Public Title of Study Study on anemia in children between 2-5 years in two districts of Scientific Title of Multiple micro nutrient intervention study for reducing anemia among children aged 2 - 5 years in Study keerapalayam block of Cudalore and Morappur block of Dharmapuri District. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Durairaj Trial Coordinator (multi-center study) Designation Additional Director, Directorate of Public Health and Preventive Medicine Affiliation Office of Director Of Public Health and Preventive medicine Address Dr. Durairaj, Office of Director Of Public Health and Preventive medicine, Government of Tamil Nadu, Chennai 600 006 Chennai TAMIL NADU 600 006 Phone 04424321569 Fax 0449176863980 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Kolandaisamy Query) Designation Joint Director Affiliation Director of Public Health & Preventive medicine Address Office of Director Of Public Health and Preventive medicine, Government of Tamil Nadu, Chennai 600 006 Chennai TAMIL NADU 600 006 India Phone 9444329907 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Kolandaisamy Designation Joint Director Affiliation Director of Public Health & Preventive medicine Address Office of Director Of Public Health and Preventive medicine, Government of Tamil Nadu, Chennai 600 006 Chennai TAMIL NADU 600 006

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India Phone 9444329907 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > H J Heinz Nutrition Foundation of India > National Rural Health Mission India Primary Sponsor Primary Sponsor Details Name National Rural Health Mission India Address State Health Society, NRHM, Directorate of public health and preventive medicine. Chennai 600 006 Type of Sponsor Government funding agency Details of Secondary Name Address Sponsor H J Heinz Nutrition Foundation of India 3AB, 3rd Floor, Century Plaza, 560 Anna Salai, Chennai 600018. Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Anthony Raj Keerapalayam Primary Helath centre 04144257219 Keerapalayam Block, district [email protected] Cuddalore TAMIL NADU Dr R Jeevanantham Morappur PHC Block Medical officer, 04346263035 Morappur Primary Health Centre, dpi-morappur.tnphc@ni Morappur, Dharmapuri c.in district Tamil Nadu Dharmapuri TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Instutional Ethics Approved 28/04/2011 Yes committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers All the children satisfying inclusion and exclusion criteria. Children with Hb% 7 is treated separately as per standard available approach by the medical officer of the primary health centre. Intervention / Type Name Details Comparator Agent Comparator Agent Iron and folic acid tablets / syrup This is routinely given to form children by Govt of India. it is being practiced for several years. Intervention Nurturemate: Trial substance Nutrient Quantity This is a Composition: Active intervention nutritional supplement mixed : Nurturemate powder (FDA with food and given to children

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License no once daily for sixty days. MKV/VLK/UMR/541/6110. Vitamin A (Vitamin A acitate) Issued on 20-05-2005 expiring 375 mg Vitamin B1(Thiamine on 31-3-2012) Monotrate) 0.5mg Vitamin B2(Riboflovin) 0.5mg Vitamin B6(Pyridoxine) 0.5mg Vitamin B12(Cyanocobalamine) 0.9mg Vitamin C (Ascorbic Acid) 35 mg Vitamin D2(Ergocalciferol) 5 mg Vitamin E (Vitamin E Acetate) 6 mg Folic Acid 0.15 mg Niacin (Niacinamide) 6 mg Copper (Copper sulphate) 0.6mg Iodine (Pottassium Iodide) 50 mg Iron(Ferrus Fumerate) 12.5 mg Zinc(Zinc gluconate) 5 mg Inclusion Criteria Inclusion Criteria Age From 2.00 Year(s) Age To 5.00 Year(s) Gender Both Details All children born between 14-4-2006 and 13-4-2009 are eligible. A child should be a resident(living in the study area) of the study area. Exclusion Criteria Exclusion Criteria Details Children with severe illness in any form, hospitalized, or currently treated for any ailment in any form. Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Compliance,and adherence to trial product Baseline,and the daily data entered by the intake. Completing 90% of the trial products parents in the diary card of children until the end within the stipulated period of intervention is of the treatment period. considered as complete adherence. Secondary Outcome Outcome Timepoints Estimation of hemoglobin level in the study area. Base line ,at the end of treatment and after one year - Hb% adverse effect if any adverse effect - during treatment period Target Sample Size Total Sample Size=1800 Sample Size from India=1800 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 3 Date of First 06/06/2011 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable

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Trial (Global) Recruitment Status of Completed Trial (India) Publication Details nil Brief Summary On going programmes for anemia control are

The National Anemia Control Programme

The Integrated Child Development Scheme (ICDS)

The Adolescent Anemia Control Programme

The National Nutritional Anemia Control Programme ( NNACP )

Under this NNACP , the Pre-school children were one of the target groups to receive IFA tablets /Syrup 20 mg of elemental iron (60 mg of ferrous sulphate) and 0.1 mg of folic acid under the National Nutritional Anemia Prophylaxis Programme since 1970. But the Anemia status among this age group is not improving. The stake holders feel the practical difficulties of administering iron tablet / syrup to children.

The Iron syrup is also found to be inconvenient for the community distribution as they have to be carefully measured before use, have a metallic unpleasant taste, and the opened bottle requires to be stored in the room temperature carefully for 100 days without contamination. This iron supplementation programs face challenges with compliance and supply as a result there has been very little impact in terms of reduction in anemia in childhood.

Micro nutrients added along with the cooked food was found to reduce anemia in efficacy trials in a variety of contexts. In a study report of Ghana it is demonstrated that a single daily dose of micro-encapsulated ferrous fumarate sprinkles plus ascorbic acid resulted in a successful treatment of anaemia without side effects. In a study report of Pakistan the daily provision of micro-nutrients (including zinc) reduces the longitudinal prevalence of diarrhoea and thus may also reduce diarrhoea related mortality in young children(aged 6-12 months). Efficacy study done jointly by the King Edward Memorial Hospital Research Center in Pune, and the Hospital for Sick Children in Toronto, Canada among anemic children in rural areas of Pune demonstrated that one sachet daily of Sprinkles containing 12.5 mg of iron

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effectively treated anemia among children aged 6-24 months with in a brief two months period. During this period mean hemoglobin(Hb) increased from 8.8g/dl to 10.1 g/dl and anemia prevalence decreased from 100% to 47%.

The above studies indicate that Home fortification with a blend of vitamins and minerals manufactured in powdered form is an innovative strategy to increase the content of iron and other micronutrients in the food given to the child either at home or at Noon meal center to prevent anaemia in children.

But no studies have been carried out on strategies to mainstream the programme along with the ongoing regular Maternal Child Health Programme and the cost effectiveness when it is expanded in large scale in programme mode. Hence it is proposed to study on

Primary objective

To determine level of compliance in the two interventions in a programme mode

Secondary objective

To estimate hemoglobin level

To estimate the occurrence of side effects/ adverse events and acute morbidities

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