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Examining the efficacy of different iron supplements in women

Examining the efficacy of different iron supplements (Maltofer and Ferrograd C) in women with low serum ferritin concentrations

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000529640
Acronym
The WISE study (Women and Iron Supplementation Efficacy)
Enrollment
63
Registered
2023-05-19
Start date
2023-08-15
Completion date
2024-12-09
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Iron deficiency is one of the most common health conditions globally, and disproportionally affects women, comparative to men (Pasricha et al., 2021). Specifically, the menstrual cycle can negatively affect iron regulation, with low-estrogen periods of been prohibitive for iron absorption and menstrual blood loss resulting in a direct, and often substantial loss of body iron (McKay et al., 2022). Additionally, high exercise volumes can also be detrimental to iron status, with direct iron losses (via GI bleeding, haemolysis and sweat) and exercise-induced decreases in iron absorption been contributors to the high prevalence of iron deficiency in athletic populations (Peeling et al., 2008). Accordingly, female athletes need to combat both the sex- and exercise-associated challenges to iron regulation, making them a ‘high risk’ cohort for iron deficiency. One approach for correcting an iron deficiency is to use oral iron supplementation. A conventional supplementation regime consists of daily ferrous sulphate dose (~100 mg of elemental iron), usually found in combination with a source of vitamin C which typically increases an athlete’s iron stores by 30-50% over a 6–8-week period (Dawson et al., 2006; Hinton et al., 2000). However, it is not uncommon for individuals to report high levels of gastrointestinal distress from this treatment, especially athletes. Other formulations have been identified which claim to reduce the side effects associated with iron ingestion. One such formulation, is an iron(III)-hydroxide polymaltose complex (Maltofer), which has shown good efficacy and reduced side effects in pregnant women (Ortiz et al., 2011), however it’s use in athlete cohorts has not yet been determined. Accordingly, this study will assess to efficiency of different iron formulations in different cohorts of women with varying exercise loads and menstrual statuses. It is hypothesised that both supplements will be equally effective at increasing iron stores, however Maltofer consumption will be associated with lower GI complaints. Furthermore, we hypothesise that iron stores will be repleted faster in generally active, compared to athlete cohorts, and that menopausal women will have the greatest increase in their iron stores after 12 weeks. Collectively, this work may highlight the need to develop athlete-specific strategies for the treatment iron deficiency. The aims of this project are: 1. To assess the efficacy of two different iron formulations (Ferrograd C and Maltofer) on the treatment of low iron stores in women. 2. To compare the efficacy of oral iron supplementation in different cohorts of women. 3. To assess the relationship between iron status, supplement efficacy and the TMPRSS6 rs855791 (2321 C>T) polymorphism in women.

Interventions

1 x Maltofer Iron Tablets per day for 12 weeks. A single supplement contains 370 mg iron polymaltose (equivalent to 100 mg or elemental iron). Adherence will be monitored via completion of a daily survey, where participants will be asked to record what time of day (if applicable) they took the supplement. Empty supplement bottles will also be returned at 4-week intervals. Subjects will be allocated to supplement group based on a requirement to match serum ferritin levels between supplement gr

1 x Maltofer Iron Tablets per day for 12 weeks. A single supplement contains 370 mg iron polymaltose (equivalent to 100 mg or elemental iron). Adherence will be monitored via completion of a daily survey, where participants will be asked to record what time of day (if applicable) they took the supplement. Empty supplement bottles will also be returned at 4-week intervals. Subjects will be allocated to supplement group based on a requirement to match serum ferritin levels between supplement groups (Ferrograd C vs Maltofur) and cohort (endurance athletes, team sport athletes, active women and menopausal women). This will occur by a CI involved not involved in the data collection phase of the study. The TMPRSS6 rs855791 (2321 C>T) polymorphism will be analysed at the screening stage in women (via the same venous blood sample), with polymorphism type having no bearing or impact on the drug allocation.

Sponsors

Australian Catholic University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Females with serum ferritin concentrations below 50 ug/L.. Must also fit one of the below groups: 1. Female endurance athletes, aged 18-40 years old, must be running ~40 km per week or more; naturally menstruating; 2. Team sport athletes, aged 18-40 years old, must be participating in structured training at least 3 times/ week; naturally menstruating. 3. Active Women, aged 18-40 years old, naturally menstruating; must meet WHO’s criteria for physically active, however not meeting the training threshold or competing in endurance/team sports. 4. Postmenopausal women, aged 40-70 years old, deemed post-menopausal; not using hormonal replacement therapy; must meet WHO’s criteria for physically active, however not meeting the training threshold or competing in endurance/team sports.

Exclusion criteria

The exclusion criteria for all participants includes use of hormonal contraception, pregnant, chronic diseases (i.e., diabetes, cancer, heart diseases) and/or a recent iron infusion (within 12 weeks). All participants must be willing to abstain from oral iron supplementation for 14 days prior to the first measurement.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026