IronNCT04477018
16 Weeks' Dietary Supplementation With Iron and Iron + Vitamin C on Cerebral Blood Flow and Energy Expenditure in Women of Reproductive Age
A study testing Iron bis-glycinate chelate and vitamin C and Iron bis-glycinate chelate in people with Iron and Cerebral Blood Flow, run by Northumbria University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron, Cerebral Blood Flow, Energy Metabolism
- What is being tested?
- Iron bis-glycinate chelate and vitamin C and Iron bis-glycinate chelate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2017to 8 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Female
- Aged 18-49 (inclusive)
- Have a BMI of between 18.5-40
- Have an English bank account (required for payment)
Who cannot join
- 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
Show all 18Show fewer
- 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
- 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
- Any health condition that would prevent fulfilment of the study requirements
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance & Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
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.
Read the detailed description
Each participant will be required to attend the laboratory on four 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. Participants who fell into the iron status category of iron sufficient (haemoglobin ≥120 g/L and serum ferritin > 20 µg/L) or non-anaemic iron deficient (haemoglobin ≥120 g/L and serum ferritin ≤ 20 µg/L) will be informed of their eligibility for the intervention study by email or phone between the initial visit and their next. This will include the option to enrol in an additional assessment of neuroimaging and energy metabolism.
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. Following this, participants are informed of their iron status and will be briefed regarding the requirements of the intervention study and additional assessment. Following this, informed consent will be obtained prior to starting the additional assessment. Participants will have a frequency domain near-infrared spectroscopy headband attached to the forehead to measure cerebral blood flow at rest for five minutes. Following this, participants will instead have a continuous wave near-infrared spectroscopy headband attached to the forehead to measure cerebral blood flow, and a face mask fitted to measure expired air. Participants will have another five minute rest before completing an additional battery of cognitive tasks for approximately 35-40 minutes. Once complete, participants will be randomised to one of three treatments and be provided with a treatment diary to log treatment consumption and any adverse events experienced.
Participants will return to the laboratory after 8 weeks to exchange treatment bottles and diaries in order to check compliance.
Participants will finally return to the laboratory after a further 8 weeks (16 weeks total). The same procedures will take place prior to cognitive and mood testing as completed at the baseline testing visit, with the addition of finger prick and venous blood sample and weight measurement. Participants will then complete the same cognitive, mood and neuroimaging and energy metabolism assessments as completed during the baseline testing visit.
- Conditions
- Iron, Cerebral Blood Flow, Energy Metabolism, Cognitive Function
- Being tested
- Iron bis-glycinate chelate and vitamin C, Iron bis-glycinate chelate, Placebo
- Keywords
- Iron supplementation, Cerebral blood flow, Near infrared spectroscopy, Indirect calorimetry, Energy metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron bis-glycinate chelate and vitamin CDietary supplement
28 mg iron; 240 mg vitamin C
Iron bis-glycinate chelateDietary supplement
28 mg iron only
PlaceboDietary supplement
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Iron and Vitamin C | Experimental | 28 mg iron bis-glycinate chelate and 240 mg vitamin C Receives: Dietary Supplement: Iron bis-glycinate chelate and vitamin C |
| Iron | Active comparator | 28 mg iron bis-glycinate chelate Receives: Dietary Supplement: Iron bis-glycinate chelate |
| Placebo | Placebo comparator | Matched placebo tablets Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow
Near Infrared Spectroscopy outcomes for cerebral blood flow measurement at rest and during cognitive demand
Measured: 16 weeks
Secondary outcomes (8)
Serial Subtraction Performance
Performance on serial subtractions (3s and 7s) will be assessed as total responses and total errors
Measured: 16 weeks
Rapid Visual Information Processing
Performance is assessed as accuracy (%), correct reaction time (msec) and false alarms
Measured: 16 weeks
Subjective alertness
Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance. Scores range from 0 to 100. Higher scores are indicative of greater feelings of alertness.
Measured: 16 weeks
Subjective fatigue
Subjective mental fatigue will be derived from a Mental Fatigue visual analogue scale presented following cognitive task performance. Scores range from 0 to 100. Higher scores are indicative of greater feelings of mental fatigue.
Measured: 16 weeks
Fat Oxidation
Fat oxidation will be assessed through indirect calorimetry at rest and during cognitive demand
Measured: 16 weeks
Carbohydrate Oxidation
Carbohydrate oxidation will be assessed through indirect calorimetry at rest and during cognitive demand
Measured: 16 weeks
Respiratory Energy Ratio
Respiratory energy ration will be assessed through indirect calorimetry at rest and during cognitive demand
Measured: 16 weeks
Total Energy Expenditure
Total energy expenditure will be assessed through indirect calorimetry at rest and during cognitive demand
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start11 Nov 2017
- Primary completion8 Jun 2019
- Study completion8 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IronStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive either iron and vitamin C, iron alone or placebo for a period of 16 weeks to consume daily
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477018
- Sponsor's protocol ID
- 9BN2
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 16 Weeks' Dietary Supplementation With Iron and Iron + Vitamin C on Cerebral Blood Flow and Energy Expenditure in Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT04477018
- Acronym / sponsor ID
- 9BN2
- Conditions
- Iron, Cerebral Blood Flow, Energy Metabolism, Cognitive Function
- Keywords
- Iron supplementation, Cerebral blood flow, Near infrared spectroscopy, Indirect calorimetry, Energy metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 8 Jun 2019 (actual)
- Study completion
- 8 Jun 2019 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each participant will be required to attend the laboratory on four 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. Participants who fell into the iron status category of iron sufficient (haemoglobin ≥120 g/L and serum ferritin > 20 µg/L) or non-anaemic iron deficient (haemoglobin ≥120 g/L and serum ferritin ≤ 20 µg/L) will be informed of their eligibility for the intervention study by email or phone between the initial visit and their next. This will include the option to enrol in an additional assessment of neuroimaging and energy metabolism.
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. Following this, participants are informed of their iron status and will be briefed regarding the requirements of the intervention study and additional assessment. Following this, informed consent will be obtained prior to starting the additional assessment. Participants will have a frequency domain near-infrared spectroscopy headband attached to the forehead to measure cerebral blood flow at rest for five minutes. Following this, participants will instead have a continuous wave near-infrared spectroscopy headband attached to the forehead to measure cerebral blood flow, and a face mask fitted to measure expired air. Participants will have another five minute rest before completing an additional battery of cognitive tasks for approximately 35-40 minutes. Once complete, participants will be randomised to one of three treatments and be provided with a treatment diary to log treatment consumption and any adverse events experienced.
Participants will return to the laboratory after 8 weeks to exchange treatment bottles and diaries in order to check compliance.
Participants will finally return to the laboratory after a further 8 weeks (16 weeks total). The same procedures will take place prior to cognitive and mood testing as completed at the baseline testing visit, with the addition of finger prick and venous blood sample and weight measurement. Participants will then complete the same cognitive, mood and neuroimaging and energy metabolism assessments as completed during the baseline testing visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will receive either iron and vitamin C, iron alone or placebo for a period of 16 weeks to consume daily
| Arm | Type | Receives |
|---|---|---|
| Iron and Vitamin C | Experimental | Dietary Supplement: Iron bis-glycinate chelate and vitamin C28 mg iron bis-glycinate chelate and 240 mg vitamin C |
| Iron | Active comparator | Dietary Supplement: Iron bis-glycinate chelate28 mg iron bis-glycinate chelate |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatched placebo tablets |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- Female
- Aged 18-49 (inclusive)
- Have a BMI of between 18.5-40
- Have an English bank account (required for payment)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron bis-glycinate chelate and vitamin C28 mg iron; 240 mg vitamin C | Dietary supplement | Iron and Vitamin C |
| Iron bis-glycinate chelate28 mg iron only | Dietary supplement | Iron |
| PlaceboMatched placebo | Dietary supplement | Placebo |
Primary outcome
Cerebral Blood Flow
Time frame: 16 weeks
Near Infrared Spectroscopy outcomes for cerebral blood flow measurement at rest and during cognitive demand
8 secondary outcomes
Serial Subtraction Performance
Time frame: 16 weeks
Rapid Visual Information Processing
Time frame: 16 weeks
Subjective alertness
Time frame: 16 weeks
Subjective fatigue
Time frame: 16 weeks
Fat Oxidation
Time frame: 16 weeks
Carbohydrate Oxidation
Time frame: 16 weeks
Respiratory Energy Ratio
Time frame: 16 weeks
Total Energy Expenditure
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron bis-glycinate chelate and vitamin C and Iron bis-glycinate chelate in people with Iron and Cerebral Blood Flow, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Blood Flow (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.