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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Cornell University

    Ithaca, New York, 14853

Other trials in United States

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.

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 groups in NCT04363905
Study groupRoleWhat they receive
PlaceboPlacebo comparator100 mg lactose capsule
Receives: Dietary Supplement: Placebo
Ferrous sulfateExperimental20 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.

  1. Marker of iron status: Hemoglobin

    g/L

    Measured: 6 weeks

  2. Marker of iron status: serum ferritin

    ug/L

    Measured: 6 weeks

  3. Marker of iron status: serum transferrin receptor

    mg/L

    Measured: 6 weeks

  4. Marker of iron status: serum iron

    umol/L

    Measured: 6 weeks

  5. Marker of iron status: total iron binding capacity

    umol/L

    Measured: 6 weeks

  6. Marker of iron status: transferrin saturation

    Measured: 6 weeks

Secondary outcomes (2)
  1. Physical performance

    Submaximal and maximal cycling ergometry was used to assess physical performance

    Measured: 6 weeks

  2. 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.

  1. First posted27 Apr 2020
  2. Study start1 Apr 2000
  3. Primary completion31 Aug 2000
  4. Study completion31 Dec 2000

Resources

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)
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

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.

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