Iron Deficiency (Without Anemia)NCT04363905
Supplemental Iron Improves Submaximal Exercise Performance in Non-anemic Iron Depleted Women
A study testing Ferrous sulfate in people with Iron Deficiency (Without Anemia), run by Cornell University at 1 site in United States.
Trial summary
The specific aims of the current study were: 1) To determine the prevalence of IDNA in a sample of Mexican women of reproductive age and 2) To determine how iron supplementation in IDNA women influences physical work capacity during submaximal exercise . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (Without Anemia)
- What is being tested?
- Ferrous sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2000to 31 Dec 2000
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoking
Who cannot join
- acute or chronic injury or illness at time of screening, hemolytic anemia
- physician-diagnosed asthma, musculoskeletal problems, or eating disorders
- pregnant or lactating, pregnant with the previous year
- excessive alcohol consumption or recent use of recreational drugs
- recent history of eating disorders, or use of prescription medications and/or vitamin or mineral supplements that would interfere with dietary iron absorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplemental Iron Improves Submaximal Exercise Performance in Non-anemic Iron Depleted Mexican Women: A Randomized Placebo Control Trial
The specific aims of the current study were: 1) To determine the prevalence of IDNA in a sample of Mexican women of reproductive age and 2) To determine how iron supplementation in IDNA women influences physical work capacity during submaximal exercise . The researchers hypothesized that marginally iron depleted women will have improved physical work capacity during submaximal intermittent exercise tests after dietary iron supplementation. However, no improvement in peak maximal oxygen consumption after dietary iron supplementation because they will remain non-anemic.
Read the detailed description
Recent estimates of the prevalence of anemia among non-pregnant Mexican women of reproductive age range from 15 percent for a nationally representative sample from the 1988 National Nutrition Survey to 29 percent for low socioeconomic women from the PROGRESA baseline survey of 1998 (Mexican Ministry of Health, unpublished report). The cause of most of this anemia is iron deficiency. It can be assumed that time between 15 and 30 percent of Mexican women also experience iron deficiency without also experiencing anemia. In some studies of anemic women, iron deficiency has been shown to result in reduced physical performance as measured by VO2max (the oxygen consumption at maximum physical exertion), presumably due to reduced oxygen (02) transport related to the reduced hemoglobin (Hb) concentration. However, no effects of iron deficiency have been shown on VO2max in women who were not anemic. Given that Hb concentration is not reduced in iron deficient non anemic women, it is expected that VO2max remains unaffected. However, this less severe form of iron deficiency may still affect physical performance. The important role of iron in the synthesis of many of the enzymes involved in oxidative metabolism suggests that moderate levels of iron deficiency may impair muscular energy transformation at levels of exertion that are not as severe as those reflected in VO2max. The choice of the appropriate sub maximal physical performance test is therefore critical to successful demonstration of the effects of moderate iron deficiency on response to exercise stress.
In this study the investigators proposed to test the effects of iron deficiency on physical performance using a randomized double blind design that assigns marginally iron depleted, physically active women between 18 and 45 years to two treatments. One half of the women will be randomly assigned to a group that receives a daily oral iron supplement (20 mg of elemental iron as slow release ferrous sulfate) while the remaining women received a placebo. Investigators anticipated that iron supplementation would replete iron body stores in all women and increase Hb only in those who are marginally anemic. Investigators tested the physical performance response to iron treatment with two exercise tests. It was hypothesized that VO2max would not be affected by iron supplementation. A graded submaximal exertion test (30 60% of VO2max) to estimate energy expenditure (EE), gross efficiency (GE), and net efficiency (NE) was administered to test for an increase in work efficiency due to iron supplementation.
This study has important implications for the definition of dietary iron requirements in this segment of the Mexican population. The physical performance test used in this study (EE, GE, and NE), while well recognized, have never been applied to this type of research question nor has it been examined in relation to endurance performance in Mexican women. Investigators believe that previous reliance on the VO2max test to measure performance has biased conclusions toward concern only for the anemic subject, while the less severe forms of iron deficiency have been considered benign.
This study, if successful in supporting the stated hypotheses, will serve as further confirm the deleterious effects of iron deficiency without anemia and justify future research on more practical measures of performance related to female economic productivity and time and effort allocated to child care and household responsibilities.
- Conditions
- Iron Deficiency (Without Anemia)
- Being tested
- Placebo, Ferrous sulfate
- Keywords
- iron deficient non-anemic, supplementation, randomized control trial, submaximal intermittent exercise, serum ferritin, body iron
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
100 mg lactose per day for 6 weeks
Ferrous sulfateDietary supplement
20 mg per day of elemental iron for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 100 mg lactose capsule Receives: Dietary Supplement: Placebo |
| Ferrous sulfate | Experimental | 20 mg ferrous sulfate and lactose capsule Receives: Dietary Supplement: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marker of iron status: Hemoglobin
g/L
Measured: 6 weeks
Marker of iron status: serum ferritin
ug/L
Measured: 6 weeks
Marker of iron status: serum transferrin receptor
mg/L
Measured: 6 weeks
Marker of iron status: serum iron
umol/L
Measured: 6 weeks
Marker of iron status: total iron binding capacity
umol/L
Measured: 6 weeks
Marker of iron status: transferrin saturation
Measured: 6 weeks
Secondary outcomes (2)
Physical performance
Submaximal and maximal cycling ergometry was used to assess physical performance
Measured: 6 weeks
Fatigue resistance
Maximal voluntary static contractions (MVCs) with dynamic knee extensions was used to assess fatigue
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Apr 2000
- Primary completion31 Aug 2000
- Study completion31 Dec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency (Without Anemia)Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Salud Publica, Mexico
- Responsible party
- Sponsor
- Investigators
- Jere D Haas, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363905
- Sponsor's protocol ID
- 012002
- Status last verified
- Mar 2022
- First submitted
- 11 Oct 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brutsaert TD, Hernandez-Cordero S, Rivera J, Viola T, Hughes G, Haas JD. Iron supplementation improves progressive fatigue resistance during dynamic knee extensor exercise in iron-depleted, nonanemic women. Am J Clin Nutr. 2003 Feb;77(2):441-8. doi: 10.1093/ajcn/77.2.441.
PubMed 12540406
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Iron Improves Submaximal Exercise Performance in Non-anemic Iron Depleted Mexican Women: A Randomized Placebo Control Trial
- ClinicalTrials.gov ID
- NCT04363905
- Acronym / sponsor ID
- 012002
- Conditions
- Iron Deficiency (Without Anemia)
- Keywords
- iron deficient non-anemic, supplementation, randomized control trial, submaximal intermittent exercise, serum ferritin, body iron
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Instituto Nacional de Salud Publica, Mexico
- Study start
- 1 Apr 2000 (actual)
- Primary completion
- 31 Aug 2000 (actual)
- Study completion
- 31 Dec 2000 (actual)
- First posted
- 27 Apr 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.
The specific aims of the current study were: 1) To determine the prevalence of IDNA in a sample of Mexican women of reproductive age and 2) To determine how iron supplementation in IDNA women influences physical work capacity during submaximal exercise . The researchers hypothesized that marginally iron depleted women will have improved physical work capacity during submaximal intermittent exercise tests after dietary iron supplementation. However, no improvement in peak maximal oxygen consumption after dietary iron supplementation because they will remain non-anemic.
Detailed description
Recent estimates of the prevalence of anemia among non-pregnant Mexican women of reproductive age range from 15 percent for a nationally representative sample from the 1988 National Nutrition Survey to 29 percent for low socioeconomic women from the PROGRESA baseline survey of 1998 (Mexican Ministry of Health, unpublished report). The cause of most of this anemia is iron deficiency. It can be assumed that time between 15 and 30 percent of Mexican women also experience iron deficiency without also experiencing anemia. In some studies of anemic women, iron deficiency has been shown to result in reduced physical performance as measured by VO2max (the oxygen consumption at maximum physical exertion), presumably due to reduced oxygen (02) transport related to the reduced hemoglobin (Hb) concentration. However, no effects of iron deficiency have been shown on VO2max in women who were not anemic. Given that Hb concentration is not reduced in iron deficient non anemic women, it is expected that VO2max remains unaffected. However, this less severe form of iron deficiency may still affect physical performance. The important role of iron in the synthesis of many of the enzymes involved in oxidative metabolism suggests that moderate levels of iron deficiency may impair muscular energy transformation at levels of exertion that are not as severe as those reflected in VO2max. The choice of the appropriate sub maximal physical performance test is therefore critical to successful demonstration of the effects of moderate iron deficiency on response to exercise stress.
In this study the investigators proposed to test the effects of iron deficiency on physical performance using a randomized double blind design that assigns marginally iron depleted, physically active women between 18 and 45 years to two treatments. One half of the women will be randomly assigned to a group that receives a daily oral iron supplement (20 mg of elemental iron as slow release ferrous sulfate) while the remaining women received a placebo. Investigators anticipated that iron supplementation would replete iron body stores in all women and increase Hb only in those who are marginally anemic. Investigators tested the physical performance response to iron treatment with two exercise tests. It was hypothesized that VO2max would not be affected by iron supplementation. A graded submaximal exertion test (30 60% of VO2max) to estimate energy expenditure (EE), gross efficiency (GE), and net efficiency (NE) was administered to test for an increase in work efficiency due to iron supplementation.
This study has important implications for the definition of dietary iron requirements in this segment of the Mexican population. The physical performance test used in this study (EE, GE, and NE), while well recognized, have never been applied to this type of research question nor has it been examined in relation to endurance performance in Mexican women. Investigators believe that previous reliance on the VO2max test to measure performance has biased conclusions toward concern only for the anemic subject, while the less severe forms of iron deficiency have been considered benign.
This study, if successful in supporting the stated hypotheses, will serve as further confirm the deleterious effects of iron deficiency without anemia and justify future research on more practical measures of performance related to female economic productivity and time and effort allocated to child care and household responsibilities.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo100 mg lactose capsule |
| Ferrous sulfate | Experimental | Dietary Supplement: Ferrous sulfate20 mg ferrous sulfate and lactose capsule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- non-smoking
Key exclusion criteria (5 listed)
- acute or chronic injury or illness at time of screening, hemolytic anemia
- physician-diagnosed asthma, musculoskeletal problems, or eating disorders
- pregnant or lactating, pregnant with the previous year
- excessive alcohol consumption or recent use of recreational drugs
- recent history of eating disorders, or use of prescription medications and/or vitamin or mineral supplements that would interfere with dietary iron absorption
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 |
|---|---|---|
| Placebo100 mg lactose per day for 6 weeks | Dietary supplement | Placebo |
| Ferrous sulfate20 mg per day of elemental iron for 6 weeks | Dietary supplement | Ferrous sulfate |
Primary outcome
Marker of iron status: Hemoglobin
Time frame: 6 weeks
g/L
Marker of iron status: serum ferritin
Time frame: 6 weeks
ug/L
Marker of iron status: serum transferrin receptor
Time frame: 6 weeks
mg/L
Marker of iron status: serum iron
Time frame: 6 weeks
umol/L
Marker of iron status: total iron binding capacity
Time frame: 6 weeks
umol/L
Marker of iron status: transferrin saturation
Time frame: 6 weeks
2 secondary outcomes
Physical performance
Time frame: 6 weeks
Fatigue resistance
Time frame: 6 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 22 Mar 2022.
- Background: PubMed 12540406Brutsaert TD, Hernandez-Cordero S, Rivera J, Viola T, Hughes G, Haas JD. Iron supplementation improves progressive fatigue resistance during dynamic knee extensor exercise in iron-depleted, nonanemic women. Am J Clin Nutr. 2003 Feb;77(2):441-8. doi: 10.1093/ajcn/77.2.441.
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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.
Jere D Haas, PhD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous sulfate in people with Iron Deficiency (Without Anemia), run by Cornell University at 1 site in United States.
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 1 inclusion and 5 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 22 Mar 2022. 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 States. 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?
Marker of iron status: Hemoglobin (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363905, which also lists 1 linked publication.
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 22 Mar 2022.