The Relationship Between Iron Status, Cognitive Performance, Subjective Mood and Fatigue in Women of Reproductive Age.

NCT04257669 | Completed

• 1 other identifier: 9BM1
• Study Type: observational
• Target: 379
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Iron Status

Keywords

Iron Status; Iron deficiency; Cognition; Mood; Fatigue; Well-being; Women's Health

Outcome Measures

Primary Outcomes (2)

• Speed of attention

  An overall score for Speed of attention will be derived by calculating the average score from 3 separate standardised task outcomes (ZChoice reaction time correct reaction time + ZRapid visual information processing correct reaction time + ZDigit vigilance correct reaction time) /3

  Baseline measure

• Subjective fatigue

  Subjective fatigue will be derived from the total score of the Piper Fatigue Scale. Scores range from 1 to 10. Higher scores are indicative of greater fatigue.

  Baseline measure

Secondary Outcomes (14)

• Episodic memory

  Baseline measure

• Speed of memory

  Baseline measure

• Accuracy of attention

  Baseline measure

• Executive function

  Baseline measure

• Speed of executive function

  Baseline measure

Study Arms (4)

Iron sufficient

Haemoglobin ≥120g/L Serum ferritin \> 20μg/L

Non-anaemic iron deficient

Haemoglobin ≥120g/L Serum ferritin ≤ 20μg/L

Iron deficient anaemic

Haemoglobin \<120g/L Serum ferritin ≤ 20μg/L

Anaemic without iron deficiency

Haemoglobin \<120g/L Serum ferritin \> 20μg/L

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Must be female at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Healthy
• Female
• Aged 18-49 (inclusive)
• Have a BMI of between 18.5-40
• Have an English bank account (required for payment)

You may not qualify if:

• Aged under 18 or over 49
• BMI lower than 18.5 or higher than 40
• Pre-existing medical condition/illness with some exceptions - please check with researcher
• Blood disorders (excluding anaemia) or any known active infections
• Current or past breast cancer diagnosis and/or mastectomy
• Smoking or use of any nicotine replacement products e.g. vaping, gum, patches
• Pregnant, trying to get pregnant or breast feeding
• Currently taking any prescription medication with some exceptions - please check with researcher
• Regular use of dietary/herbal supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
• Use of iron supplements within the past 4 months
• Have donated more than 300ml of blood in the past 3 months
• History of significant head trauma or suffer from frequent migraines that require medication (more than or equal to one per month)
• Learning difficulties, dyslexia, or colour blindness
• Visual impairment that cannot be corrected with glasses or contact lenses
• Currently taking part in any other clinical or nutritional intervention studies or have in the past 4 weeks

Sponsors & Collaborators

• Northumbria University: lead
• Bayer: collaborator

Study Sites (1)

Brain, Performance & Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

Related Publications (4)

• Scott SP, Murray-Kolb LE. Iron Status Is Associated with Performance on Executive Functioning Tasks in Nonanemic Young Women. J Nutr. 2016 Jan;146(1):30-7. doi: 10.3945/jn.115.223586. Epub 2015 Dec 9.

  PMID: 26661838 BACKGROUND

• Murray-Kolb LE, Beard JL. Iron treatment normalizes cognitive functioning in young women. Am J Clin Nutr. 2007 Mar;85(3):778-87. doi: 10.1093/ajcn/85.3.778.

  PMID: 17344500 BACKGROUND

• Blanton CA, Green MW, Kretsch MJ. Body iron is associated with cognitive executive planning function in college women. Br J Nutr. 2013 Mar 14;109(5):906-13. doi: 10.1017/S0007114512002620. Epub 2012 Jun 7.

  PMID: 22676919 BACKGROUND

• Fordy J, Benton D. Does low iron status influence psychological functioning? Journal of Human Nutrition and Dietetics 115: 167-183, 1994.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum for serum ferritin analysis

MeSH Terms

Conditions

Iron Deficiencies; Fatigue

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 6, 2020
• Study Start: May 19, 2017
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: February 6, 2020

Record last verified: 2019-03

Locations

GB (1)