NCT01383798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

June 27, 2011

Last Update Submit

March 13, 2014

Conditions

Keywords

iron deficiency, physical performance, female athletes

Outcome Measures

Primary Outcomes (1)

  • Markers of iron status

    6 weeks

Secondary Outcomes (1)

  • Physical performance outcomes

    6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Red capsule (50 mg) lactose

Dietary Supplement: Placebo

Ferrous sulfate

EXPERIMENTAL
Dietary Supplement: Ferrous sulfate

Interventions

PlaceboDIETARY_SUPPLEMENT

100 mg lactose per day for 6 weeks

Placebo
Ferrous sulfateDIETARY_SUPPLEMENT

100 mg per day of ferrous sulfate for 6 weeks

Ferrous sulfate

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Metabolic Research Unit, MVR Hall, Cornell University

Ithaca, New York, 14853, United States

Location

Related 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. doi: 10.1123/ijsnem.21.6.501.

  • 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.

  • 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.

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jere D. Haas, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR
  • Diane M. DellaValle, PhD

    Cornell University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations