NCT04363905

Brief 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 . 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2000

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2000

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2000

Completed
18.8 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

October 11, 2019

Last Update Submit

March 8, 2022

Conditions

Iron Deficiency (Without Anemia)

Keywords

iron deficient non-anemicsupplementationrandomized control trialsubmaximal intermittent exerciseserum ferritinbody iron

Outcome Measures

Primary Outcomes (6)

  • Marker of iron status: Hemoglobin

    g/L

    6 weeks

  • Marker of iron status: serum ferritin

    ug/L

    6 weeks

  • Marker of iron status: serum transferrin receptor

    mg/L

    6 weeks

  • Marker of iron status: serum iron

    umol/L

    6 weeks

  • Marker of iron status: total iron binding capacity

    umol/L

    6 weeks

  • Marker of iron status: transferrin saturation

    6 weeks

Secondary Outcomes (2)

  • Physical performance

    6 weeks

  • Fatigue resistance

    6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

100 mg lactose capsule

Dietary Supplement: Placebo

Ferrous sulfate

EXPERIMENTAL

20 mg ferrous sulfate and lactose capsule

Dietary Supplement: Ferrous sulfate

Interventions

PlaceboDIETARY_SUPPLEMENT

100 mg lactose per day for 6 weeks

Placebo
Ferrous sulfateDIETARY_SUPPLEMENT

20 mg per day of elemental iron for 6 weeks

Ferrous sulfate

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-smoking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell University

Ithaca, New York, 14853, United States

Location

Related Publications (1)

  • 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.

    PMID: 12540406BACKGROUND

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

April 27, 2020

Study Start

April 1, 2000

Primary Completion

August 31, 2000

Study Completion

December 31, 2000

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

US(1)