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Iron Deficiency (Without Anemia)NCT01383798

How Does Iron Supplementation Affect Training and Performance in Female Collegiate Rowers?

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 female rowers at the beginning of a training season; 2) To determine how IDNA affects endurance training and performance at the beginning of a training season; 3) To determine how iron supplementation affects iron… Read more about this study

Who is it for?
Ages 18 to 30 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
40 participants
Where
1 siteUnited States
Study dates
Aug 2008to Dec 2009
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 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • non-smoking
  • current member of college/university rowing team

Who cannot join

  • acute or chronic injury or illness at time of screening
  • physician-diagnosed asthma, musculoskeletal problems, or eating disorders
  • pregnant or lactating
  • use of steroids or other performance-enhancing substances

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Human Metabolic Research Unit, MVR Hall, Cornell University

    Ithaca, New York, 14853

Other trials in United States

About this study

Official title: How Does Iron Deficiency Without Anemia (IDNA) Affect Endurance Training In Female Collegiate Endurance Athletes?

The specific aims of the current study were: 1) To determine the prevalence of IDNA in a sample of female rowers at the beginning of a training season; 2) To determine how IDNA affects endurance training and performance at the beginning of a training season; 3) To determine how iron supplementation affects iron status, training and performance in IDNA female collegiate rowers. The researchers hypothesized that IDNA affects endurance performance in female collegiate rowers both in and outside of the laboratory, and that iron supplementation of IDNA rowers will improve iron status, and consequently, training quality via increased energetic efficiency.

Read the detailed description

Iron deficiency (ID) is the most common nutrient deficiency in the United States, affecting 13% of pre-menopausal women, and approximately 30% of physically-active women (1, 2). Iron deficiency anemia (IDA) is clinically defined as hemoglobin (Hgb) less than 12.0 g/dl. Iron depletion without anemia (IDNA), or low iron stores, is defined as Hgb greater than 12.0 g/dl and serum ferritin (sFer) less than 20.0 µg/L. Female athletes are at higher risk of IDNA due to their menstrual status, poor dietary intake, and high training volume and intensity (3). Consequences of IDNA that may be relevant to athletes include reduced work capacity, endurance, and energetic efficiency (4-6); and increased local muscle fatigue (7). The mechanism by which IDNA affects endurance and physical performance remains unclear, and the functional consequences of IDNA are not fully understood in trained individuals, as studies to examine these relationships have been underpowered (8, 9).

Our lab has previously reported the effects of iron deficiency on physical performance in untrained, IDNA women adapting to an aerobic training program. Hinton et al (5) showed that the effect of iron supplementation on physical performance was mediated by changes in iron status (sFer), and concluded that IDNA reduces the potential benefits of aerobic training on endurance. In that study, subjects who were supplemented with iron for 6 weeks during aerobic training improved their time to complete a 15-km cycling time trial by 3.4 min compared to 1.6 min in the placebo group (p<0.05). Given these convincing results, the study of highly-trained competitive female athletes training at a high volume and intensity was warranted. We expected these significant effects to persist in competitive collegiate athletes. However, we expected the magnitude of these effects to be somewhat less due to collegiate athletes' advanced training status, and thus a smaller margin of improvement in performance due to response of increased body iron stores. The goal of the proposed study was to determine whether marginal iron deficiency (IDNA) impairs the ability of moderately- to highly-trained female collegiate rowers to increase their training quality, as well as their performance in response to 6 weeks of iron supplementation, in addition to their usual endurance training.

This study was conducted in three phases. Phase 1 was a cross-sectional study designed to describe the iron status of a diverse sample of female collegiate rowers around central New York state. Iron status was screened with a venous blood sample, and demographic and other health and self-reported performance data were also collected. One-hundred and sixty-five female collegiate endurance athletes were screened to identify IDNA subjects (sFer <20 µg/l, Hgb >12 g/dL) for an iron supplementation trial.

Phase 2 was a cross-sectional study designed to measure and compare the metabolic and functional consequences of ID in a sample of highly-trained female rowers across a broad range of both fitness levels (novice to varsity)and iron status (normal, ID, and IDNA). This cross-sectional study was an analysis of the baseline data for potential RCT participants (IDNA) at the beginning of a training season. In addition to those IDNA subjects participating in the supplementation trial, we included a sample of non-anemic, non-iron deficient rowers. These subjects completed all baseline protocols in the lab, and recorded one week of training activities, in addition to all other baseline data collected. This cross-sectional study enabled us to investigate potential relationships between iron status and early training season performance.

This plausibility analysis was useful, in light of the putative mechanisms (correlations between iron status and physical performance), to explain how iron status may affect physical performance. These analyses suggested relationships between iron status and performance, but did not provide strong causal evidence, as temporal relationships between iron status and performance cannot be determined in a cross-sectional study. We did, however, need to identify and control confounding factors related to both iron status and performance to control bias.

Phase 3 was a randomized, placebo-controlled supplementation trial designed to explore how IDNA and iron supplementation affect iron status, performance, and training over 6-weeks of rowing training. Rowers with normal iron status were included in this study to examine training effects (if any) on iron status and performance. This study was designed to elucidate the cause-effect relationship(s) between iron status (and iron supplementation), training and performance.

Being tested
Placebo, Ferrous sulfate
Keywords
iron deficiency, physical performance, female athletes
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

    100 mg per day of ferrous sulfate for 6 weeks

Study groups in NCT01383798
Study groupRoleWhat they receive
PlaceboPlacebo comparatorRed capsule (50 mg) lactose
Receives: Dietary Supplement: Placebo
Ferrous sulfateExperimentalNot described
Receives: Dietary Supplement: Ferrous sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Markers of iron status

    Measured: 6 weeks

Secondary outcomes (1)
  1. Physical performance outcomes

    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 posted28 Jun 2011 (estimated)
  2. Study startAug 2008
  3. Primary completionDec 2009
  4. Study completionDec 2009

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01383798
Sponsor's protocol ID
OSP 57149
Status last verified
Mar 2014
First submitted
27 Jun 2011
Last updated
14 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • DellaValle DM, Haas JD. Impact of iron depletion without anemia on performance in trained endurance athletes at the beginning of a training season: a study of female collegiate rowers. Int J Sport Nutr Exerc Metab. 2011 Dec;21(6):501-6. doi: 10.1123/ijsnem.21.6.501.

    PubMed 22089308
  • Dellavalle DM, Haas JD. Iron status is associated with endurance performance and training in female rowers. Med Sci Sports Exerc. 2012 Aug;44(8):1552-9. doi: 10.1249/MSS.0b013e3182517ceb.

    PubMed 22382172
  • DellaValle DM, Haas JD. Iron supplementation improves energetic efficiency in iron-depleted female rowers. Med Sci Sports Exerc. 2014 Jun;46(6):1204-15. doi: 10.1249/MSS.0000000000000208.

    PubMed 24195864

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 2 inclusion and 4 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 14 Mar 2014. 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?

Markers of iron status (time frame: 6 weeks). 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 NCT01383798, which also lists 3 linked publications.

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 14 Mar 2014.

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