Clinical trial NCT04363905: Supplemental Iron Improves Submaximal Exercise Performance in Non-anemic Iron Depleted Women
Official title: Supplemental Iron Improves Submaximal Exercise Performance in Non-anemic Iron Depleted Mexican Women: A Randomized Placebo Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency (Without Anemia)
Keywords: iron deficient non-anemic
supplementation
randomized control trial
submaximal intermittent exercise
serum ferritin
body iron
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Salud Publica, Mexico
First posted: 2020-04-27
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Recent estimates of the prevalence of anemia among non-pregnant Mexican women of reproductive age range from 15 percent for a nationally representative sample from the 1988 National Nutrition Survey to 29 percent for low socioeconomic women from the PROGRESA baseline survey of 1998 (Mexican Ministry of Health, unpublished report). The cause of most of this anemia is iron deficiency. It can be assumed that time between 15 and 30 percent of Mexican women also experience iron deficiency without also experiencing anemia. In some studies of anemic women, iron deficiency has been shown to result in reduced physical performance as measured by VO2max (the oxygen consumption at maximum physical exertion), presumably due to reduced oxygen (02) transport related to the reduced hemoglobin (Hb) concentration. However, no effects of iron deficiency have been shown on VO2max in women who were not anemic. Given that Hb concentration is not reduced in iron deficient non anemic women, it is expected that VO2max remains unaffected. However, this less severe form of iron deficiency may still affect physical performance. The important role of iron in the synthesis of many of the enzymes involved in oxidative metabolism suggests that moderate levels of iron deficiency may impair muscular energy transformation at levels of exertion that are not as severe as those reflected in VO2max. The choice of the appropriate sub maximal physical performance test is therefore critical to successful demonstration of the effects of moderate iron deficiency on response to exercise stress.

In this study the investigators proposed to test the effects of iron deficiency on physical performance using a randomized double blind design that assigns marginally iron depleted, physically active women between 18 and 45 years to two treatments. One half of the women will be randomly assigned to a group that receives a daily oral iron supplement (20 mg of elemental iron as slow release ferrous sulfate) while the remaining women received a placebo. Investigators anticipated that iron supplementation would replete iron body stores in all women and increase Hb only in those who are marginally anemic. Investigators tested the physical performance response to iron treatment with two exercise tests. It was hypothesized that VO2max would not be affected by iron supplementation. A graded submaximal exertion test (30 60% of VO2max) to estimate energy expenditure (EE), gross efficiency (GE), and net efficiency (NE) was administered to test for an increase in work efficiency due to iron supplementation.

This study has important implications for the definition of dietary iron requirements in this segment of the Mexican population. The physical performance test used in this study (EE, GE, and NE), while well recognized, have never been applied to this type of research question nor has it been examined in relation to endurance performance in Mexican women. Investigators believe that previous reliance on the VO2max test to measure performance has biased conclusions toward concern only for the anemic subject, while the less severe forms of iron deficiency have been considered benign.

This study, if successful in supporting the stated hypotheses, will serve as further confirm the deleterious effects of iron deficiency without anemia and justify future research on more practical measures of performance related to female economic productivity and time and effort allocated to child care and household responsibilities.

Eligibility criteria: Inclusion Criteria:

* non-smoking

Exclusion Criteria:

* 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

Primary outcomes:
measure: Marker of iron status: Hemoglobin
timeFrame: 6 weeks
measure: Marker of iron status: serum ferritin
timeFrame: 6 weeks
measure: Marker of iron status: serum transferrin receptor
timeFrame: 6 weeks
measure: Marker of iron status: serum iron
timeFrame: 6 weeks
measure: Marker of iron status: total iron binding capacity
timeFrame: 6 weeks
measure: Marker of iron status: transferrin saturation
timeFrame: 6 weeks
Secondary outcomes:
measure: Physical performance
timeFrame: 6 weeks
measure: Fatigue resistance
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
Study officials:
affiliation: Cornell University
name: Jere D Haas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.