Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000773730
Ethics application status
Approved
Date submitted
26/06/2013
Date registered
10/07/2013
Date last updated
10/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Iron, Selenium, and Mood Study
Scientific title
Associations between iron levels or selenium levels and mood in a young adult sample.
Secondary ID [1] 282558 0
NIL
Universal Trial Number (UTN)
U1111-1143-4090
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mood 289223 0
depression 289224 0
self-reported physical and cognitive function 289583 0
Condition category
Condition code
Mental Health 289558 289558 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 289559 289559 0 0
Depression
Diet and Nutrition 289913 289913 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
At the beginning of the study, participants attend a laboratory session and complete a questionnaire assessing demographics and depression status via the Center for Epidemiological Studies Depression Scale (CES-D). Each day for the next 13 days, participants complete over the Internet a daily diary survey that contains an 18-item measure of positive and negative mood (based on the circumplex model of emotion, Barrett & Russell, 1999) and several unstandardized measures of self-reported physical and cognitive function (e.g., perceived daily tiredness, feeling physically run down, difficulty concentrating). At the end of the 13-days, a blood sample is taken to analyse iron and selenium levels, which will be analysed in relation to CES-D scores, daily positive and negative affect, and daily physical and cognitive function.
Intervention code [1] 287223 0
Not applicable
Comparator / control treatment
Not applicable - Observational Study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289654 0
daily positive and negative mood, as measured by the 18-item circumplex measure of mood
Timepoint [1] 289654 0
daily over the two-week period
Primary outcome [2] 289655 0
depression, as measured by the CES-D
Timepoint [2] 289655 0
beginning of the two-week observational period
Secondary outcome [1] 302961 0
daily self-reported physical and cognitive function (unstandardized variables)
Timepoint [1] 302961 0
daily over the two-week period

Eligibility
Key inclusion criteria
Males or female young adults aged 18-25 years
Cellphone/internet access
Willingness to provide a blood sample
Enrolled as a student at the University of Otago part-time or full-time
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Multiple regression to detect associations between iron status and primary outcomes and selenium status and primary outcomes

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2011
Actual
28/03/2011
Date of last participant enrolment
Anticipated
2/08/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 5098 0
New Zealand
State/province [1] 5098 0
Otago

Funding & Sponsors
Funding source category [1] 287337 0
Government body
Name [1] 287337 0
Health Research Council of New Zealand - Emerging Researcher First Grant
Country [1] 287337 0
New Zealand
Primary sponsor type
Individual
Name
Dr Tamlin Conner
Address
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 286083 0
Individual
Name [1] 286083 0
Dr Anne-Louise Heath
Address [1] 286083 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country [1] 286083 0
New Zealand
Secondary sponsor category [2] 286084 0
Individual
Name [2] 286084 0
Dr Lisa Houghton
Address [2] 286084 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country [2] 286084 0
New Zealand
Secondary sponsor category [3] 286085 0
Individual
Name [3] 286085 0
Dr Jody Miller
Address [3] 286085 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country [3] 286085 0
New Zealand
Secondary sponsor category [4] 286086 0
Individual
Name [4] 286086 0
Ms Aimee Richardson
Address [4] 286086 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
Country [4] 286086 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289312 0
Human Ethics Committee
Ethics committee address [1] 289312 0
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 289312 0
New Zealand
Date submitted for ethics approval [1] 289312 0
Approval date [1] 289312 0
13/10/2010
Ethics approval number [1] 289312 0
10/177

Summary
Brief summary
The purpose of this project is to determine whether two micronutrients - iron and selenium - each may be associated with differences in depression, mood, and self-reported physical and cognitive function among a sample of young adults in New Zealand. In this study, mood and self-reported physical and cognitive function will be tracked using computerised daily diaries for 13 days. This is a more sensitive measure of symptom tracking that has not yet been used in the previous research on these micronutrients. Depression will also be assessed using the CES-D. Studies have found that iron deficiency anaemia is associated with increased fatigue and higher depression. However, it is not clear whether iron deficiency without anaemia is associated with these factors. Studies have also found that reduced selenium levels are associated with increased depressive symptoms. New Zealand has low levels of selenium in the soil, particularly in Otago where the study participants are based. Studies examining the association between selenium and depression or mood in a New Zealand sample are limited.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40278 0
Dr Tamlin Conner
Address 40278 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
Country 40278 0
New Zealand
Phone 40278 0
+6434797624
Fax 40278 0
Email 40278 0
[email protected]
Contact person for public queries
Name 40279 0
Dr Tamlin Conner
Address 40279 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
Country 40279 0
New Zealand
Phone 40279 0
+6434797624
Fax 40279 0
Email 40279 0
[email protected]
Contact person for scientific queries
Name 40280 0
Dr Tamlin Conner
Address 40280 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
Country 40280 0
New Zealand
Phone 40280 0
+6434797624
Fax 40280 0
Email 40280 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
SourceTitleYear of PublicationDOI
EmbaseHigher body iron is associated with greater depression symptoms among young adult men but not women: Observational data from the daily life study.2015https://dx.doi.org/10.3390/nu7085270
N.B. These documents automatically identified may not have been verified by the study sponsor.