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CTRI Number  CTRI/2017/07/009131 [Registered on: 27/07/2017] Trial Registered Retrospectively
Last Modified On: 24/07/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   A study to reduce anemia in school going children with a low cost iron and vitamin c, tasty fizzy drink. 
Scientific Title of Study   Efficacy trial for a low cost Iron with Vitamin C drink for reducing Anemia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anura V Kurpad  
Designation  Professor of Physiology and Head, Division of Nutrition 
Affiliation  St. John’s Medical College 
Address  Dept. of Physiology St. John’s Medical College, Bangalore, Karnataka , India

Bangalore
KARNATAKA
560034
India 
Phone  08049467000  
Fax    
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anura V Kurpad  
Designation  Professor of Physiology and Head, Division of Nutrition 
Affiliation  St. John’s Medical College 
Address  Dept. of Physiology St. John’s Medical College, Bangalore, Karnataka , India

Bangalore
KARNATAKA
560034
India 
Phone  08049467000  
Fax    
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Dr Anura V Kurpad  
Designation  Professor of Physiology and Head, Division of Nutrition 
Affiliation  St. John’s Medical College 
Address  Dept. of Physiology St. John’s Medical College, Bangalore, Karnataka , India

Bangalore
KARNATAKA
560034
India 
Phone  08049467000  
Fax    
Email  a.kurpad@sjri.res.in  
 
Source of Monetary or Material Support  
Jamsetji Tata Trust. Bombay House, 24 Homi Mody Street, Mumbai 400001 India 
 
Primary Sponsor  
Name  Jamsetji Tata Trust 
Address  Bombay House,24 Homi Mody Street Mumbai 400001  
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anura V Kurpad   St. Johns Research Institute  Division of Nutrition, Room # 410, 3rd Floor, Medical college building.
Bangalore
KARNATAKA 
08049467000

a.kurpad@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Iron deficient Indian School children of the age group 07-11 years of both genders.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Placebo i.e Potassium bicarbonate and Sugar  will be administrated in 100 ml of water at school during mid-morning daily for a duration of four months 
Comparator Agent  self-dispersible effervescent tablets contain 6mg iron/serving as ferrous bisglycinate along with 40mg of ascorbic acid  will be administered in 100 ml of water at school during mid-morning daily for a duration of four months  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  1.Aged 7-11 years
2.Low socioeconomic status
3.Serum Ferritin <30 µg/L
 
 
ExclusionCriteria 
Details  1.Severe anemia (Hb<8g/dL)
2.Female with onset of menarche
3.Elevated serum CRP (>10 mg/L)
4.Need for any chronic prescription or over-the-counter medication
5.Intention to leave the school during the course of this study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Serum Ferritin
Hb
serum transferrin receptor
C - reactive protein 
Baseline and End line  
 
Secondary Outcome  
Outcome  TimePoints 
height and weight  Baseline and End line  
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
Final Enrollment numbers achieved (Total)= "136"
Final Enrollment numbers achieved (India)="136" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/09/2016 
Date of Study Completion (India) 20/04/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1. World Health Organization. Guidelines on food fortification with micronutrients for the control of micronutrient malnutrition. Geneva: WHO; 2004. 2.International Institute for Population Sciences. National Family Health Survey II, (NFHS-II). Mumbai, India; 1999. 3.Thankachan P, Muthayya S, Walczyk T, Kurpad AV, Hurrell R F. An analysis of the etiology of anemia and iron deficiency in young women of low socioeconomic status in Bangalore, India. Food and Nutrition Bulletin. 2007 :( in press). 4.Charlton RW, Bothwell TH. Iron absorption. Annu Rev Med. 1983;34:55-68. 5.FairweatherTait S, Hurrell RF. Bioavailability of minerals and trace elements. Nutr Res Rev. 1996;9:295-324. 6.Torre M, Rodriguez AR, Saura-Calixto F. Effects of dietary fiber and phytic acid on mineral availability. Crit Rev Food SciNutr. 1991;30(1):1-22. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Iron deficiency (ID) and iron deficiency anemia (IDA) are globally considered as the most prevalent nutrient deficiency in the world. The sheer number of lives affected worldwide is shocking, It is estimated that 2 billion people worldwide are iron deficient including one billion who suffer from IDA(1). In India, 74% of the children below 5 years of age and 52% of young women have anemia (2). Poor dietary iron intake (3) and decreased iron absorption are the two main factors responsible for nutritional iron deficiency affecting poor populations (4). Plant based diets commonly consumed in

India and other developing countries have low iron content and also contain an abundance of phytates and polyphenols that inhibit the absorption of dietary non-heme iron (5), by forming insoluble complexes, thereby making it unavailable for absorption (6, 7). Rice is predominantly consumed and iron content of rice-based diets could be in the range of about 7mg/1000 Kcal. Data from an unpublished survey of primary school children in Karnataka, where the median iron intake was found to be about 10 mg/day. Assuming a generous bioavailability of 5% across all intakes, the median iron absorbed would be about 0.5 mg/day. Thus for a child with 1mg iron as the physiological requirement per day he/she will have a daily deficit of0.5 mg/day, or half the

child’s requirement is only met. Over the days and years this deficit accrues and is further worsened by the increase in iron requirement around puberty.

 
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