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

Phase 2

Completed

• Conditions: Non-anemic Iron Deficiency
• Interventions: Dietary Supplement: Blood Builder®/Iron Response®

• Registration Number: NCT02683369
• Lead Sponsor: University of Maryland, Baltimore

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iron Supplement	Blood Builder®/Iron Response®	Participants will consume one tablet of Blood Builder®/Iron Response®, once per day, every day, for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in Serum Ferritin (SF) Level	Baseline and study end (8 weeks from baseline)	Marker of iron status
Changes in Total Body Iron Stores	Baseline and study end (8 weeks from baseline)	Marker of iron status
Changes in Hemoglobin (Hgb) Level	Baseline and study end (8 weeks from baseline)	Marker of iron status
Changes in Soluble Transferrin Receptor (sTfR) Level	Baseline and study end (8 weeks from baseline)	Marker of iron status

Secondary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Center for Integrative Medicine University of Maryland; 🇺🇸 Baltimore, Maryland, United States