Efficacy Evaluation of 16 Weeks' Dietary Supplementation With Iron Bis-glycinate Plus Vitamin C on Cognitive Function, Subjective Mood, Fatigue, Health and Well-being

NCT04469010 | Completed

• 1 other identifier: 9BN1
• Study Type: interventional
• Target: 151
• 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. However, randomised controlled trials (RCTs) assessing the effect of iron supplementation upon cognitive performance, mood, fatigue and well-being in non-anaemic iron deficient women of reproductive age are limited. There is also a lack of well-defined diagnostic criteria for non-anaemic iron deficiency, which makes comparisons across RCTs difficult. However, there is evidence to suggest that a haemoglobin cut off of ≥120 g/L and serum ferritin ≤ 20 µg/L provides an accurate indication of non-anaemic iron deficiency in women of reproductive age; this is inclusive of the ability to recognise iron-associated deficits in psychological and physiological functioning. Additionally, previous RCTs could be improved by utilising a lower dose of iron in a bis-glycinate chelate form, which is evidenced to have superior bioavailability, tolerability and subsequent efficacy compared to ferrous formulations. Iron bis-glycinate absorption is also negatively associated to serum ferritin levels, which is suggestive of a non-anaemic iron deficient population benefitting most from it's administration. The current study aims to build upon previous iron RCTs in populations of non-anaemic iron deficient and iron sufficient women of reproductive age by investigating the effects of 16-weeks supplementation with either iron bis-glycinate chelate alone, iron bis-glycinate plus vitamin C (as ascorbic acid) or matched placebo upon cognitive performance, subjective mood, fatigue, health and well-being.

Conditions

Cognitive Function and Mood; Non-anaemic Iron Deficiency

Keywords

Cognition; Mood; Fatigue; Well-being; Women's health; Iron supplementation; Vitamin C

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

  16 weeks

• 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.

  16 weeks

Secondary Outcomes (14)

• Accuracy of episodic memory

  16 weeks

• Speed of episodic memory

  16 weeks

• Accuracy of attention

  16 weeks

• Accuracy of executive function

  16 weeks

• Speed of executive function

  16 weeks

Study Arms (3)

Iron and Vitamin C

EXPERIMENTAL

28mg iron bis-glycinate chelate and 240mg vitamin C

Dietary Supplement: Iron Bis-Glycinate Chelate and Vitamin C

Iron

ACTIVE COMPARATOR

28mg iron bis-glycinate chelate

Dietary Supplement: Iron Bis-Glycinate Chelate

Placebo

PLACEBO COMPARATOR

Matched placebo tablets

Dietary Supplement: Placebo

Interventions

Iron Bis-Glycinate Chelate and Vitamin C DIETARY_SUPPLEMENT

28 mg iron 240 mg vitamin C

Iron and Vitamin C

Iron Bis-Glycinate Chelate DIETARY_SUPPLEMENT

28 mg iron

Iron

Placebo DIETARY_SUPPLEMENT

Matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Participants must be female as assigned at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 above 49 years
• BMI lower than 18.5 or higher than 40
• Pre-existing medical condition/illness with some exceptions - please check with researcher
• Blood disorders (including 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
• Food allergies/sensitivities relevant to the study
• 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
• Have haemoglobin levels below 120g/L
• 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

Sponsors & Collaborators

• Northumbria University: lead
• Bayer: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Fatigue

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive either iron and vitamin C, iron alone or placebo for a period of 16 weeks to consume daily

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 13, 2020
• Study Start: June 2, 2017
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: July 13, 2020

Record last verified: 2019-07

Locations

GB (1)