Iron Deficiency (Without Anemia) Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
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 |