Iron Status Clinical Trial
Official title:
The Relationship Between Iron Status, Cognitive Performance, Subjective Mood and Fatigue in Women of Reproductive Age
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).
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.
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