The Relationship Between Iron Status, Cognitive Performance, Subjective Mood and Fatigue in Women of Reproductive Age.
Condition: Iron Status
MeSH terms: Fatigue
Study type: Observational

Summary: 
      Iron deficiency is the most prevalent nutritional deficiency worldwide with one in four
      estimated to be affected by iron deficiency anaemia. Women of reproductive age are at
      greatest risk for iron deficiency and anaemia due to iron losses during menstruation and
      childbirth as well as the increased need for iron throughout pregnancy. However, iron
      deficiency without anaemia is at least twice as common as iron deficiency anaemia with
      females aged 11-49 at the biggest risk of all. Despite this, it is commonly left undiagnosed.
      Those who are iron deficient non-anaemic can still suffer from the same common consequences
      of iron deficiency anaemia; these include unexplained fatigue, mood changes and decreased
      cognitive performance. Previous studies have found a significant relationship between iron
      status and cognitive performance in anaemic women. However, studies assessing cognition, mood
      and fatigue in women of varying iron status including those who are iron deficient nonanaemic
      are lacking. The most recent observational study of this kind found that better iron status
      was associated with better sustained attention but worse working memory. However, iron
      deficient anaemic females were not included in this observation. This study will extend upon
      this in order to determine any differences between non-anaemic iron deficiency and iron
      deficiency anaemia. The aims of this study are to improve knowledge concerning women's health
      and to determine whether there is a relationship between iron status, cognitive performance,
      subjective mood and fatigue in women of reproductive age (18-49 years).
    

Detailed description: 
      Each participant will be required to attend the laboratory on two occasions. The first is
      comprised of a screening/training visit, which will take place in the afternoon for
      approximately 2.5 hours. This will also be between days 21-28/the week before onset of their
      menstrual cycle. If they do not have menstrual bleeds then this appointment can be any
      afternoon. This will comprise: briefing of requirements of the study; obtaining of informed
      consent; confirmation of eligibility to take part, including collection of demographic data
      and health screening, and training on the cognitive and mood measures. The training session
      will follow standard operating procedures to decrease the chance of learning effects during
      main trials. Extra training will be given where necessary.

      Participants will be required to complete questionnaires based upon food frequency, caffeine
      consumption and to estimate the number of hours of exercise completed on a weekly basis. A
      menstrual cycle questionnaire will also be completed to estimate menstrual blood loss and so
      that participants attend their testing visit during days 7-14 of their cycle. If participants
      do not have a menstrual cycle due to contraceptive methods, then appointments will be
      approximately two weeks apart.

      A finger-prick and venous blood sample will be collected from participants, which will be
      analysed for iron status. Those whose haemoglobin levels are <120g/L will be advised to seek
      advice from their GP.

      For the testing visit, participants will be asked to fast for 12 hours prior to the visit,
      avoiding intake of all food and drink with the exception of water. They will also be asked to
      avoid alcohol and refrain from intake of 'over the counter' medication for 24 hours.
      Participants will arrive at the laboratory at a designated time in the morning. The following
      procedures will take place prior to cognitive and mood testing:

        -  Review of continued conformity to eligibility criteria

        -  Adverse event and concomitant medication assessment

        -  Ensure that participant is in good health

      Participants will then complete the baseline cognitive and mood assessments.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Females aged 18-49 who meet the inclusion criteria who are based in Newcastle-upon-Tyne,
        United Kingdom and the residing North-East area.
      
Biospecimen description: 
      Blood serum for serum ferritin analysis
    
Keywords: Iron Status; Iron deficiency; Cognition; Mood; Fatigue; Well-being; Women's Health