None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 150 non-anaemic women aged 18 to 50 years with blood ferritin levels below 30 µg/L and self-reported fatigue will be randomly assigned to receive 30mg of elemental iron from microencapsulated iron pyrophosphate or ferrous bisglycinate (in combination with 70mg of vitamin C), or a matching placebo for 12 weeks. Changes in self-reported fatigue, mood, brain fog, sleep quality, restless legs, and gastrointestinal symptoms will be assessed over time. Changes in cognitive performance, as assessed by computer-based tests, blood iron stores, complete blood count, heart rate variability, and body composition, will also be examined.
Interventions
Randomised and equal allocation to either (1) Microencapsulated iron pyrophosphate (delivering 30 mg of elemental iron) + 70mg vitamin C, or (2) Ferrous bisglycinate (delivering 30 mg of elemental iron) + 70mg of vitamin C (1 capsule taken orally, once daily, in the morning on an empty stomach for 12 weeks). Adherence to capsule intake will be measured by a count of capsules returned at week 12.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Menstruating women 2. Age 18 to 50 years 3. Ferritin levels below 30 µg/L 4. Self-reported fatigue/ low energy 5. Non-smoker 6. BMI between 18 and 35 kg/m2 7. Understand, willing and able to comply with all study procedures 8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. Haemoglobin levels < 120 g/L, indicating anaemia. 2. Suffering from a recently diagnosed or uncontrolled medical condition including but not limited to: severe menstrual problems including heavy bleeding or lengthy periods; unmanaged gastrointestinal disease; history of gastric surgery; cardiovascular disease; cancer/malignancy; liver disease; iron overload condition (e.g., hemochromatosis, hemosiderosis, hemoglobinopathies); stomach ulcers; diabetes; hyper/hypotension, gallbladder disease/gallstones/biliary disease, autoimmune disease, or endocrine disease. 3. Planning to provide blood donation during the study period 4. Diagnosis of a severe psychiatric disorder (other than mild-to-moderate depression or anxiety) or neurological disease, including but not limited to Parkinson’s disease, Alzheimer’s disease, and uncontrolled epilepsy. 5. Regular medication intake, including but not limited to proton pump inhibitors, antacids, histamine-2 receptor antagonists, nonsteroidal anti-inflammatory drugs, and antibiotics. 6. Change in medication in the last 3 months or an expectation to change during the study duration 7. Taking iron supplements or vitamins, herbal, or other nutritional supplements reasonably expected to influence study outcomes. 8. Current or 12-month history of regular illicit drug use 9. Alcohol intake greater than 14 standard drinks per week 10. Pregnant, breastfeeding, or an intention to fall pregnant in the next 3 months 11. Planned major lifestyle or dietary changes or surgeries during the study period
Outcome results
None listed