16 Weeks' Dietary Supplementation With Iron and Iron + Vitamin C on Cerebral Blood Flow and Energy Expenditure in Women of Reproductive Age

NCT04477018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2020-07-20

No results posted yet for this study

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. It is postulated that for any cognitive and behavioural change to occur, a complementary change in neural functioning is required. A recent cross-sectional study has identified increases in cognitive demand to produce decrements in measures of cognitive performance and increases in brain activity and metabolic measures; the magnitude of such are evidenced to be directly related to iron status. However, such measures do not provide an estimate of overall oxygen consumption that is specific to the brain in order to be able to associate changes in cognitive performance and energy expenditure specifically to the brain itself. The current study aims to investigate the parallel effects of iron supplementation on cerebral haemodynamics and energy metabolism to determine the ability of iron to modulate whole body energy metabolism and utilisation of metabolic substrates at rest and during cognitive demand in a sample of non-anaemic iron deficient and iron sufficient women of reproductive age.

Conditions

  • Iron
  • Cerebral Blood Flow
  • Energy Metabolism
  • Cognitive Function

Interventions

DIETARY_SUPPLEMENT

Iron bis-glycinate chelate and vitamin C

28 mg iron; 240 mg vitamin C

DIETARY_SUPPLEMENT

Iron bis-glycinate chelate

28 mg iron only

DIETARY_SUPPLEMENT

Placebo

Matched placebo

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY
  • Northumbria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-11
Primary Completion
2019-06-08
Completion
2019-06-08

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04477018 on ClinicalTrials.gov