Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-anemic Iron Deficiency

Intervention / Treatment
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* Dietary Supplement: Blood Builder®/Iron Response®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron Supplement<br>Participants will consume one tablet of Blood Builder®/Iron Response®, once per day, every day, for 8 weeks. | Dietary Supplement: Blood Builder®/Iron Response®<br>* The low-dose iron dietary supplement is a tablet that contains vitamins and minerals selected to help maintain healthy red blood cells and iron levels in the blood. The supplement ingredients aim to generate a supplement by taking a food which contains the naturally occurring, complex matrix of proteins, lipids, carbohydrates and all other elements associated with the vitamin or mineral of interest. These natural food sources are used to generate tablets that maintain the vitamin and mineral potency found in the original food source as well as the associated elements that naturally accompany it. One tablet will be taken once a day offering a total daily serving of: 15 mg of Vitamin C 400 mcg of Folate 30 mcg Vitamin of B-12 26 mg of Iron 125 mg of Beet Root<br>* Other names: Low-dose iron dietary supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Hemoglobin (Hgb) Level | Marker of iron status | Baseline and study end (8 weeks from baseline) | 
| Changes in Serum Ferritin (SF) Level | Marker of iron status | Baseline and study end (8 weeks from baseline) | 
| Changes in Soluble Transferrin Receptor (sTfR) Level | Marker of iron status | Baseline and study end (8 weeks from baseline) | 
| Changes in Total Body Iron Stores | Marker of iron status | Baseline and study end (8 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| Self-reported energy level |  | Baseline and study end (8 weeks from baseline) | 
| Supplement compliance assessed using participant daily diary |  | Study end (8 weeks from baseline) | 
| Adverse events |  | Study end (8 weeks from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-anemic Iron Deficiency, Iron Supplementation