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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-anemic Iron Deficiency
• Intervention / Treatment: Dietary supplement: Blood Builder®/Iron Response®

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Center for Integrative Medicine University of Maryland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Iron Supplement; Participants will consume one tablet of Blood Builder®/Iron Response®, once per day, every day, for 8 weeks.

Dietary supplement: Blood Builder®/Iron Response®; 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; Other Names: Low-dose iron dietary supplement

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Publications and helpful links

General Publications

• D'Adamo CR, Novick JS, Feinberg TM, Dawson VJ, Miller LE. A Food-Derived Dietary Supplement Containing a Low Dose of Iron Improved Markers of Iron Status Among Nonanemic Iron-Deficient Women. J Am Coll Nutr. 2018 May-Jun;37(4):342-349. doi: 10.1080/07315724.2018.1427158. Epub 2018 Mar 13.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Non-anemic Iron Deficiency, Iron Supplementation
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: 017-FS; HP-00067251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED