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Trial registered on ANZCTR


Registration number
ACTRN12611000758909
Ethics application status
Approved
Date submitted
19/07/2011
Date registered
20/07/2011
Date last updated
1/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Health of Newly Arrived Refugees with Vitamin B12 Deficiency
Scientific title
In newly arrived refugees aged 18 and over from Bhutan, Afghanistan and Iran who come to the Migrant Health Service in Adelaide, are symptoms and perception of physical, psychological and general health different in those with and without Vitamin B12 deficiency?
Secondary ID [1] 262658 0
Nil
Universal Trial Number (UTN)
U1111-1122-9705
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin B12 deficiency 268363 0
Refugee health 268369 0
Condition category
Condition code
Diet and Nutrition 268496 268496 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 268497 268497 0 0
Other metabolic disorders
Mental Health 268498 268498 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A questionnaire including the K10, the general health question from the SF-36 and questions about the symptoms of Vitamin B12 deficiency will be self-administered (with the support of health staff) in their own language by newly arrived refugees from Bhutan, Afghanistan and Iran. Some participants will have Vitamin B12 deficiency (<150pmol/L), some will have borderline Vitamin B12 (150-240pmol/L) and some will have normal Vitamin B12 levels. All participants will be treated according to usual clinical protocols with Vitamin B12 injections if they have deficiency, dietary advice if they have borderline levels and no treatment if theyhave normal Vitamin B12 levels. The questionnaire will be administered to all participants again after 4 months and those with low or borderline Vitamin B12 will have their levels repeated.
Intervention code [1] 267003 0
Not applicable
Comparator / control treatment
The controls in this study are those participants with normal Vitamin B12 levels. Answers to the questionnaire will be compared in the three groups initially and after four months. Answers to the K10 will also be compared with those from the NSW Government Health Survey (2006) and the answers to the general health question will be compared with those from the ABS National Health Survey (2004-2005).
Control group
Active

Outcomes
Primary outcome [1] 269241 0
Whether symptoms such as fatigue, irritability, memory difficulties, unusual sensations in legs and feet and psycholgocial distress are reliable indictors of Vitamin B12 deficiency in newly arrived refugees. A questionnaire consisting of the Kessler 10 (K10) Psychological Distress scale, the general health question from the SF-36 and questions about the symptoms of Vitamin B12 deficiency will be asked. Blood tests fro Vitamin B12 levels will be taken
Timepoint [1] 269241 0
Initial presentation and 4 months later
Secondary outcome [1] 279200 0
Whether symptoms and perception of health change as Vitamin B12 normalises. A questionnaire consisting of the Kessler 10 (K10) Psychological Distress scale, the general health question from the SF-36 and questions about the symptoms of Vitamin B12 deficiency will be asked. Blood tests fro Vitamin B12 levels will be taken
Timepoint [1] 279200 0
Initial presentation and 4 months later
Secondary outcome [2] 279201 0
Whether there is a difference in symptomatology and perceptions of general health in newly arrived refugees with and without Vitamin B12 deficiency. A questionnaire consisting of the Kessler 10 (K10) Psychological Distress scale, the general health question from the SF-36 and questions about the symptoms of Vitamin B12 deficiency will be asked. Blood tests fro Vitamin B12 levels will be taken
Timepoint [2] 279201 0
Initial presentation and 4 months later

Eligibility
Key inclusion criteria
Refugees aged 18 and over who present to the New Arrival Nursing Clinic at the Migrant Health Service in Adelaide in the first 3 months after arrival into Australia who are from Bhutan, Afghanistan or Iran.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged under 18 or taking Vitamin B12 supplements at the initial presentation

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267481 0
Government body
Name [1] 267481 0
Primary Health Care Research, Evaluation and Development (PHCRED)
Address [1] 267481 0
Primary Health Care Research and Information Service (PHC RIS)
Discipline of General Practice
Flinders University of South Australia
GPO Box 2100
Adelaide SA 5001
Country [1] 267481 0
Australia
Primary sponsor type
Individual
Name
Dr Jill Benson
Address
Discipline of General Practice
University of Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 266527 0
None
Name [1] 266527 0
Address [1] 266527 0
Country [1] 266527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269443 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 269443 0
Secretary
Human Research Ethics Committee
Research Ethics and compliance Unit
Research Branch
Level 7, 115 Grenfell St
University of Adelaide, SA, 5005
Ethics committee country [1] 269443 0
Australia
Date submitted for ethics approval [1] 269443 0
19/07/2011
Approval date [1] 269443 0
19/09/2011
Ethics approval number [1] 269443 0
H-188-2011
Ethics committee name [2] 269444 0
SA Department of Health Human Research Ethics Committee
Ethics committee address [2] 269444 0
Research and Ethics Policy Unit SA Health
PO Box 287 Rundle Mall
SA 5000
Ethics committee country [2] 269444 0
Australia
Date submitted for ethics approval [2] 269444 0
19/07/2011
Approval date [2] 269444 0
16/09/2011
Ethics approval number [2] 269444 0
462/07/2014

Summary
Brief summary
High levels of Vitamin B12 deficiency were recently found in some refugee groups in studies in Australia and USA (Benson, 2010; CDC, 2011). The cause of the deficiency is unknown but is thought to be due to dietary deficiency in animal source foods or because of infection with helicobacter pylori.
There is a well-known relationship of Vitamin B12 deficiency with depression and other problems such as fatigue, irritability, memory problems and unusual sensations in legs and feet (Oh, 2003). These symptoms are often used as indicators of Vitamin B12 deficiency however there have been no studies to date to determine if these are reliable indictors, or whether they are present in all refugees with Vitamin B12 deficiency. Many refugees have psychological problems, (Steel, 2009) as well as fatigue, irritability, dizziness and memory difficulties, but it is unknown whether these symptoms may also be linked to Vitamin B12 deficiency in this population.
As refugees settle into a new country their diet and psychological health is likely to change. A control group will assist in adjusting for confounding factors.
This pilot study aims to identify:
1. whether symptoms such as fatigue, irritability, memory difficulties, unusual sensations in legs and feet and psychological distress are reliable indictors of Vitamin B12 deficiency in newly arrived refugees
2. whether these symptoms change as Vitamin B12 deficiency normalises
3. whether there is a difference in symptomatology and perceptions of general health in newly arrived refugees with and without Vitamin B12 deficiency.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32893 0
Dr Jill Benson AM
Address 32893 0
Discipline of General Practice
University of Adelaide
178 North Tce,
Adelaide
SA 5000
Country 32893 0
Australia
Phone 32893 0
+61 8 82373900
Fax 32893 0
Email 32893 0
jill.benson@adelaide.edu.au
Contact person for public queries
Name 16140 0
Dr Jill Benson AM
Address 16140 0
Director, Health in Human Diversity Unit
Discipline of General Practice
University of Adelaide
SA 5005
Country 16140 0
Australia
Phone 16140 0
+61 8 83133460
Fax 16140 0
+61 8 83133511
Email 16140 0
jill.benson@adelaide.edu.au
Contact person for scientific queries
Name 7068 0
Dr Jill Benson AM
Address 7068 0
Director, Health in Human Diversity Unit
Discipline of General Practice
University of Adelaide
SA 5005
Country 7068 0
Australia
Phone 7068 0
+61 8 83133460
Fax 7068 0
+61 8 83133511
Email 7068 0
jill.benson@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary