Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000596909
Ethics application status
Approved
Date submitted
6/06/2011
Date registered
9/06/2011
Date last updated
21/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding anaemia among young children of rural Karnataka, India
Scientific title
The socioeconomic, biochemical, and nutritional determinants of anaemia and micronutrient status among 12-23 month old children living in two districts of rural Karntaka, South India
Secondary ID [1] 262316 0
Nil
Universal Trial Number (UTN)
U1111-1121-9655
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 268022 0
Iron Deficiency 268023 0
Vitamin B12 deficiency 268024 0
Folate deficiency 268025 0
Vitamin A deficiency 268026 0
Condition category
Condition code
Diet and Nutrition 268155 268155 0 0
Other diet and nutrition disorders
Blood 268175 268175 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To be measured at a single point in time in the home village of the child, during a field survey which was undertaken from August to October 2008:
Laboratory indices: Iron status, Folate status, Vitamin B12 status, Inflammation, Hemoglobinopathy, Hookworm infestation status, Malaria infection status
Nutritional intake: Low iron intake, Continued breastfeeding,
Food insecurity,
Maternal nutrition: Maternal haemoglobin and anaemia, maternal body mass index.
Child growth: Stunting, Underweight, Wasting status.
Demographics: wealth, religion, caste
Intervention code [1] 266709 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266900 0
Anaemia in children (haemoglobin <11g/dL)
Measured by automated complete blood count (Sysmex XT-2000i [Sysmex Inc, Kobe, Japan], using an adaption of the cyanmethaemoglobin technique.
Timepoint [1] 266900 0
Cross sectional study, measurements taken at a single point in time, during field survey conducted August-October 2008.
Secondary outcome [1] 276583 0
Children's Haemoglobin concentrations, measured by automated complete blood count (Sysmex XT-2000i [Sysmex Inc, Kobe, Japan], using an adaption of the cyanmethaemoglobin technique.
Timepoint [1] 276583 0
Cross sectional study, measurements taken at a single point in time, during field survey conducted August-October 2008.
Secondary outcome [2] 276584 0
Ferritin concentration, electrochemiluminescent immunoassay, ELECSYS 2010 [ELECSYS, Hi- tachi High Technologies Corporation, Tokyo, Japan
Timepoint [2] 276584 0
Cross sectional study, measurements taken at a single point in time, during field survey conducted August-October 2008.
Secondary outcome [3] 276586 0
Folate, electrochemiluminescent immunoassay, ELECSYS 2010 [ELECSYS, Hi- tachi High Technologies Corporation, Tokyo, Japan
Timepoint [3] 276586 0
Cross sectional study, measurements taken at a single point in time , during field survey conducted August-October 2008.
Secondary outcome [4] 276587 0
vitamin B12, electrochemiluminescent immunoassay, ELECSYS 2010 [ELECSYS, Hi- tachi High Technologies Corporation, Tokyo, Japan
Timepoint [4] 276587 0
Cross sectional study, measurements taken at a single point in time, during field survey conducted August-October 2008.
Secondary outcome [5] 276588 0
vitamin A (retinol binding protein): nephelometry, Siemens BM Prospec Nephelometer, Marburg, Germany.
Timepoint [5] 276588 0
Cross sectional study, measurements taken at a single point in time, during field survey conducted August-October 2008.

Eligibility
Key inclusion criteria
Child born between 12 and 23 months 30/31 days prior to the date of sampling, living in selected villages served by randomly selected subcentres of the study Primary Health Centres.
Where birth records are unavailable or carers are unaware of the specific birth date, local calendars will be used to identify important dates (eg festivals), and we will ask whether children were born before/ after these dates. We will accept ages and birth dates to within the month.
Minimum age
12 Months
Maximum age
23 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
Any child without a primary carer (mother, father, relative or responsible adult defined as older than 18 years). Where the mother is the primary carer but is younger than 18 years old, the father will be asked to provide additional consent for the child’s involvement in the study if he is older than 18 years old. Where both parents are younger than 18 years, consent attained from the mother will be confirmed by a responsible senior member of the village.

Any child living with a carer whom is unwilling or unable to give informed consent for participation in the study.
Any child currently suffering from an acute medical illness, defined as:
a. Fever – temperature >38.0 degrees Celsius
b. Tachypnoea – respiratory rate >45 resps/ minute
c. Diarrhoea > 4 soft/ watery stools per day, or bloody diarrhoea.
d. Dehydration – signs of moderate – severe dehydration, including sunken eyes, dry mucous membranes, fewer than 4 wet nappies per day, raised skin turgor, or acidotic breathing.
e. Drowsiness, excessive fatigue, lethargy.
f. Any previous blood transfusion.
g. Any other acute illness requiring immediate medical attention.
All children will be screened by a medical officer prior to enrolment. Children meeting the above criteria will be transported to the Primary Health Centre for immediate treatment.

Child refusing cooperation with the study team despite 15 minutes comforting by carer and study team – such children may be visited again later if the carer agrees.

The total number of children eligible, the number found to be unwell, the number whose carers are not willing to participate, and the total number finally enrolled in the study will be reported.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment outside Australia
Country [1] 3613 0
India
State/province [1] 3613 0
Karnataka

Funding & Sponsors
Funding source category [1] 267191 0
Charities/Societies/Foundations
Name [1] 267191 0
The Allen Foundation
Country [1] 267191 0
United States of America
Funding source category [2] 267202 0
Charities/Societies/Foundations
Name [2] 267202 0
The Allen Foundation
Country [2] 267202 0
United States of America
Primary sponsor type
Hospital
Name
Haematology Research Unit, St John's Research Institute, St Johns National Academy of Health Sciences, Bangalore, India
Address
St. John's Research Institute,
St. John's National Academy of Health Sciences,
Bangalore 560 034
Karnataka; India
Country
India
Secondary sponsor category [1] 266263 0
University
Name [1] 266263 0
Nossal Institute for Global Health
Address [1] 266263 0
Nossal Institute for Global Health
Level 4, Alan Gilbert Building
Corner of Barry and Grattan Streets (161 Barry Street)
The University of Melbourne
Carlton Victoria 3010 Australia
Country [1] 266263 0
Australia
Secondary sponsor category [2] 266272 0
Charities/Societies/Foundations
Name [2] 266272 0
The Karuna Trust
Address [2] 266272 0
#686, 16th Main, 4th T - Block Jayanagar
Bangalore - 560011
Karnataka
Country [2] 266272 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269184 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 269184 0
Melbourne Research
The Univerity of Melbourne
Level 5, Alan Gilbert Building
VIC 3010
Ethics committee country [1] 269184 0
Australia
Date submitted for ethics approval [1] 269184 0
Approval date [1] 269184 0
29/07/2008
Ethics approval number [1] 269184 0
0825639
Ethics committee name [2] 269195 0
St John's National Academy of Health Sciences Institutional Review Board
Ethics committee address [2] 269195 0
St John's National Academy of Health Sciences
Bengaluru, Karnataka
560034, India
Ethics committee country [2] 269195 0
India
Date submitted for ethics approval [2] 269195 0
Approval date [2] 269195 0
01/05/2008
Ethics approval number [2] 269195 0

Summary
Brief summary
Background: Anaemia (low haemoglobin) is highly prevalent in India. A recent national study identified that up to 80% of children and 60% of women were anaemic. Anaemia has been associated with impaired growth and development in children, and increased morbidity and maternal mortality in women. Anaemia can be due to numerous causes, particularly iron deficiency, but other causes that may contribute include folate and B12 deficiency, malaria and hookworm infection, and haemoglobinopathy. Delayed growth (stunting and wasting) are also commonly seen amongst rural Indian children. Karnataka is a large state of Southern India, where the prevalence of anaemia amongst children aged 1-2 years has been estimated at 86%.

Key questions: What what are the causes and biological types of anaemia amongst young (1-2 year) children of rural Karnataka and how could this problem best be addressed? How do poverty, food insecurity, diet and parasitic infection interact to produce anaemia?

Research design/approach: A sample of children and their mothers living in a typical rural district of Karnataka with evaluation of nutritional aspects, socioeconomic conditions, hookworm infection status and blood haemoglobin and iron status.

The participants in the study: All children aged 1-2 years of age living in villages served by the selected primary health care subcentres will be invited to participate. Mothers or carers of children will be informed about the study and invited to participate along with their child. We will conduct a questionnaire, perform anthropometry on the child and mother, and collect blood samples by venipuncture from the child, and finger prick from the mother. We will collect stool from the child.

Relevance: We seek to identify the reasons for anaemia and under-nutrition in this population to facilitate implementation of a relevant, effective prevention strategy.
Trial website
Trial related presentations / publications
Publications
Pasricha S-R, Black JF, Biggs BA, Shet AS et al. Determinants of anemia among children in rural India. Pediatrics. 2010 Jul;126(1):e140-e149

Pasricha S-R, Vijaykumar V, Prashanth N, Sudarshan H, Biggs BA, Black J, et al. A community based field research project investigating anaemia amongst young children living in rural Karnataka, India: a cross sectional study. BMC Public Health. 2009 Feb 17;9(1):59

Presentations:

Pasricha S-R, Black J, Biggs B-A, Prashanth NS, Moodie R, Sudarshan H, Shet A. Delivery of iron supplementation in rural Karnataka, India. Proceedings of the National Conference on Blood Disorders in Public Health, Atlanta, USA 2010.

Pasricha S-R, Black J, Shet A, Bhat V, Biggs B-A, Prashanth NS et al. Anaemia among young children in rural India: a cross sectional study. Proceedings of the National Conference on Blood Disorders in Public Health, Atlanta, USA 2010.

Pasricha S-R, Black J, Shet A, Bhat V, Biggs B-A, Selvaraj S, et al. An explanatory model for haemoglobin among young children in rural Karnataka, India. Physicians Week, Royal Australasian College of Physicians, Sydney, Australia 2009.

Pasricha S-R, Black J, Shet A, Bhat V, Biggs B-A, Selvaraj S, et al. The etiology of anemia in young children aged 12-23 months. Proceedings of PHOCON 2008 Annual Conference of Pediatric Hematology Oncology Chapter Indian Academy of Pediatrics. New Delhi, India; 2008
Public notes

Contacts
Principal investigator
Name 32700 0
Address 32700 0
Country 32700 0
Phone 32700 0
Fax 32700 0
Email 32700 0
Contact person for public queries
Name 15947 0
Sant-Rayn Pasricha
Address 15947 0
Nossal Institute for Global Health
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
Carlton Victoria 3010 Australia

Co affiliation:
Haematology Research Unit,
St. John's Research Institute,
St. John's National Academy of Health Sciences,
Bangalore-560 034
Karnataka; India
Country 15947 0
Australia
Phone 15947 0
+61 3 8344 9299
Fax 15947 0
+61 3 9347 6872
Email 15947 0
[email protected]
Contact person for scientific queries
Name 6875 0
Sant-Rayn Pasricha
Address 6875 0
Nossal Institute for Global Health
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
Carlton Victoria 3010 Australia

Co affiliation:
Haematology Research Unit,
St. John's Research Institute,
St. John's National Academy of Health Sciences,
Bangalore-560 034
Karnataka; India
Country 6875 0
Australia
Phone 6875 0
+61 431709123
Fax 6875 0
+61 3 9347 6872
Email 6875 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.