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
|
|
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
|
|
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. |