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

University of Maryland, Baltimore23 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-anemic Iron Deficiency

Interventions

Blood Builder®/Iron Response®DIETARY_SUPPLEMENT

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Pre-menopausal 2. Iron deficient without anemia (serum ferritin concentration \< 20 ug/L and a hemoglobin concentration \> 120 g/L) 3. Agree to continue with current diet and any dietary supplements 4. Able to understand and write English 5. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects Exclusion Criteria: 1. Daily supplementation of another iron supplement (other than multivitamin) currently or within past 2 weeks 2. Pregnant or breastfeeding females 3. History of alcohol, drug, or medication abuse 4. Known allergies to any substance in the study product 5. Donated blood in the past month or plan to do so at any time during the 8-week trial 6. Current diagnosis of inflammatory bowel disease (Crohn's or Ulcerative Colitis) 7. Taking medication that my interfere with the absorption of iron 8. Current tobacco smoker

Locations (1)

Center for Integrative Medicine University of Maryland

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Changes in Hemoglobin (Hgb) Level

Marker of iron status

Time frame: Baseline and study end (8 weeks from baseline)

Changes in Serum Ferritin (SF) Level

Marker of iron status

Time frame: Baseline and study end (8 weeks from baseline)

Changes in Soluble Transferrin Receptor (sTfR) Level

Marker of iron status

Time frame: Baseline and study end (8 weeks from baseline)

Changes in Total Body Iron Stores

Marker of iron status

Time frame: Baseline and study end (8 weeks from baseline)

Secondary Outcomes

Frequency and severity of self-reported constipation

Time frame: Study end (8 weeks from baseline)

Frequency and severity of self-reported diarrhea

Time frame: Study end (8 weeks from baseline)

Frequency and severity of self-reported nausea

Time frame: Study end (8 weeks from baseline)

Frequency and severity of self-reported vomiting

Time frame: Study end (8 weeks from baseline)

Frequency and severity of self-reported fatigue

Time frame: Baseline and study end (8 weeks from baseline)

Self-reported energy level

Data from ClinicalTrials.gov

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