ANZCTR - Registration

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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]

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

Refugee health

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Metabolic and Endocrine

Other metabolic disorders

Mental Health

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]

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]

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]

Initial presentation and 4 months later

Secondary outcome [1]

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]

Initial presentation and 4 months later

Secondary outcome [2]

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]

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

Sex

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

15/08/2011

Actual

15/10/2011

Date of last participant enrolment

Anticipated

Actual

30/10/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

139

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Primary Health Care Research, Evaluation and Development (PHCRED)

Address [1]

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]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Adelaide Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

19/07/2011

Approval date [1]

19/09/2011

Ethics approval number [1]

H-188-2011

Ethics committee name [2]

SA Department of Health Human Research Ethics Committee

Ethics committee address [2]

Research and Ethics Policy Unit SA Health
PO Box 287 Rundle Mall
SA 5000

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

19/07/2011

Approval date [2]

16/09/2011

Ethics approval number [2]

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

Dr Jill Benson AM

Address

Discipline of General Practice
University of Adelaide
178 North Tce,
Adelaide
SA 5000

Country

Australia

Phone

+61 8 82373900

Fax

jill.benson@adelaide.edu.au

Contact person for public queries

Name

Jill Benson AM

Address

Director, Health in Human Diversity Unit
Discipline of General Practice
University of Adelaide
SA 5005

Country

Australia

Phone

+61 8 83133460

Fax

+61 8 83133511

jill.benson@adelaide.edu.au

Contact person for scientific queries

Name

Jill Benson AM

Address

Director, Health in Human Diversity Unit
Discipline of General Practice
University of Adelaide
SA 5005

Country

Australia

Phone

+61 8 83133460

Fax

+61 8 83133511

jill.benson@adelaide.edu.au

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

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Documents added automatically

No additional documents have been identified.

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