Effects of a Commercially-available, Low-dose Iron Supplement (BloodBuilder®/Iron Response®) on Markers of Iron Status Among Premenopausal and Non-anemic, Iron-deficient Women
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Changes in Serum Ferritin (SF) Level
Study Overview
Brief Summary
Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose iron dietary supplement. The investigators seek to determine if the low-dose iron dietary supplement will restore iron levels to normal range with fewer side effects than typically experienced at higher doses of iron supplementation.
Detailed Description
The primary purpose of this clinical trial is to evaluate the impact of a low-dose iron dietary supplement on markers of iron status among a sample of premenopausal women that are iron-deficient without anemia. This study will also assess the incidence of mild adverse events (constipation, nausea, etc.) that are relatively common with other over the counter iron dietary supplements and that the investigators hypothesize will be reduced with this lower-dose formulation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pre-menopausal
- •Iron deficient without anemia (serum ferritin concentration < 20 ug/L and a hemoglobin concentration > 120 g/L)
- •Agree to continue with current diet and any dietary supplements
- •Able to understand and write English
- •Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
Exclusion Criteria
- •Daily supplementation of another iron supplement (other than multivitamin) currently or within past 2 weeks
- •Pregnant or breastfeeding females
- •History of alcohol, drug, or medication abuse
- •Known allergies to any substance in the study product
- •Donated blood in the past month or plan to do so at any time during the 8-week trial
- •Current diagnosis of inflammatory bowel disease (Crohn's or Ulcerative Colitis)
- •Taking medication that my interfere with the absorption of iron
- •Current tobacco smoker
Arms & Interventions
Iron Supplement
Participants will consume one tablet of Blood Builder®/Iron Response®, once per day, every day, for 8 weeks.
Intervention: Blood Builder®/Iron Response® (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in Serum Ferritin (SF) Level
Time Frame: Baseline and study end (8 weeks from baseline)
Marker of iron status
Changes in Total Body Iron Stores
Time Frame: Baseline and study end (8 weeks from baseline)
Marker of iron status
Changes in Hemoglobin (Hgb) Level
Time Frame: Baseline and study end (8 weeks from baseline)
Marker of iron status
Changes in Soluble Transferrin Receptor (sTfR) Level
Time Frame: Baseline and study end (8 weeks from baseline)
Marker of iron status
Secondary Outcomes
- Supplement compliance assessed using participant daily diary(Study end (8 weeks from baseline))
- Adverse events(Study end (8 weeks from baseline))
- Frequency and severity of self-reported constipation(Study end (8 weeks from baseline))
- Frequency and severity of self-reported diarrhea(Study end (8 weeks from baseline))
- Self-reported energy level(Baseline and study end (8 weeks from baseline))
- Frequency and severity of self-reported nausea(Study end (8 weeks from baseline))
- Frequency and severity of self-reported vomiting(Study end (8 weeks from baseline))
- Frequency and severity of self-reported fatigue(Baseline and study end (8 weeks from baseline))
Investigators
Chris D'Adamo
Director of Research Center for Integrative Medicine
University of Maryland, Baltimore