Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01383798
Other study ID # OSP 57149
Secondary ID
Status Completed
Phase N/A
First received June 27, 2011
Last updated March 13, 2014
Start date August 2008
Est. completion date December 2009

Study information

Verified date March 2014
Source Cornell University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- non-smoking

- current member of college/university rowing team

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science


Intervention

Dietary Supplement:
Placebo
100 mg lactose per day for 6 weeks
Ferrous sulfate
100 mg per day of ferrous sulfate for 6 weeks

Locations

Country Name City State
United States Human Metabolic Research Unit, MVR Hall, Cornell University Ithaca New York

Sponsors (1)

Lead Sponsor Collaborator
Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Markers of iron status 6 weeks No
Secondary Physical performance outcomes 6 weeks No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05869422 - Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women N/A
Enrolling by invitation NCT05740462 - Hydroponic Fortification and Dietary App Effect on Nutrients Level (Harvest) N/A
Completed NCT04216030 - IP Peru, Bioavailability of Iron From Potatoes N/A
Not yet recruiting NCT06264687 - Hepcidin After Intravenous Iron Treatment
Completed NCT04735848 - Plasma Hepcidin Response to Differently Dosed Iron Supplements N/A
Completed NCT04465851 - Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs N/A
Completed NCT04636060 - Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women N/A
Completed NCT05467423 - Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome N/A
Completed NCT05257343 - Efficacy of a Low Dose, Oral, Liquid Iron Supplement on Restoring Inadequate Blood Iron to Normal Levels N/A
Completed NCT03670537 - Iron Parameters in Non-anemic First Trimester Gravidas
Recruiting NCT02949765 - Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease N/A
Completed NCT03228173 - Iron Deficiency in Female State Fair Attendees N/A
Active, not recruiting NCT05500014 - Effect of Altitude on Iron Absorption in Iron Depleted Women N/A
Completed NCT06021171 - Improving the Iron Status of Athletes With Pre-, Pro- and Synbiotics N/A
Active, not recruiting NCT04228627 - Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial Phase 4
Completed NCT04363905 - Supplemental Iron Improves Submaximal Exercise Performance in Non-anemic Iron Depleted Women N/A