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

Primary Purpose

Iron Deficiency (Without Anemia)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Ferrous sulfate
Sponsored by
Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron Deficiency (Without Anemia) focused on measuring iron deficiency, physical performance, female athletes

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Human Metabolic Research Unit, MVR Hall, Cornell University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ferrous sulfate

Arm Description

Red capsule (50 mg) lactose

Outcomes

Primary Outcome Measures

Markers of iron status

Secondary Outcome Measures

Physical performance outcomes

Full Information

First Posted
June 27, 2011
Last Updated
March 13, 2014
Sponsor
Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01383798
Brief Title
How Does Iron Supplementation Affect Training and Performance in Female Collegiate Rowers?
Official Title
How Does Iron Deficiency Without Anemia (IDNA) Affect Endurance Training In Female Collegiate Endurance Athletes?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency (Without Anemia)
Keywords
iron deficiency, physical performance, female athletes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Red capsule (50 mg) lactose
Arm Title
Ferrous sulfate
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
100 mg lactose per day for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferrous sulfate
Intervention Description
100 mg per day of ferrous sulfate for 6 weeks
Primary Outcome Measure Information:
Title
Markers of iron status
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Physical performance outcomes
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jere D. Haas, PhD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diane M. DellaValle, PhD
Organizational Affiliation
Cornell University
Official's Role
Study Director
Facility Information:
Facility Name
Human Metabolic Research Unit, MVR Hall, Cornell University
City
Ithaca
State/Province
New York
ZIP/Postal Code
14853
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22089308
Citation
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.
Results Reference
result
PubMed Identifier
22382172
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.
Results Reference
result
PubMed Identifier
24195864
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.
Results Reference
result

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

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