search
Back to results

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

Primary Purpose

Non-anemic Iron Deficiency

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Blood Builder®/Iron Response®
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-anemic Iron Deficiency focused on measuring Non-anemic Iron Deficiency, Iron Supplementation

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Integrative Medicine University of Maryland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iron Supplement

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in Hemoglobin (Hgb) Level
Marker of iron status
Changes in Serum Ferritin (SF) Level
Marker of iron status
Changes in Soluble Transferrin Receptor (sTfR) Level
Marker of iron status
Changes in Total Body Iron Stores
Marker of iron status

Secondary Outcome Measures

Frequency and severity of self-reported constipation
Frequency and severity of self-reported diarrhea
Frequency and severity of self-reported nausea
Frequency and severity of self-reported vomiting
Frequency and severity of self-reported fatigue
Self-reported energy level
Supplement compliance assessed using participant daily diary
Adverse events

Full Information

First Posted
February 9, 2016
Last Updated
August 14, 2019
Sponsor
University of Maryland, Baltimore
search

1. Study Identification

Unique Protocol Identification Number
NCT02683369
Brief Title
Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-anemic Iron Deficiency
Keywords
Non-anemic Iron Deficiency, Iron Supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iron Supplement
Arm Type
Experimental
Arm Description
Participants will consume one tablet of Blood Builder®/Iron Response®, once per day, every day, for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blood Builder®/Iron Response®
Other Intervention Name(s)
Low-dose iron dietary supplement
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Hemoglobin (Hgb) Level
Description
Marker of iron status
Time Frame
Baseline and study end (8 weeks from baseline)
Title
Changes in Serum Ferritin (SF) Level
Description
Marker of iron status
Time Frame
Baseline and study end (8 weeks from baseline)
Title
Changes in Soluble Transferrin Receptor (sTfR) Level
Description
Marker of iron status
Time Frame
Baseline and study end (8 weeks from baseline)
Title
Changes in Total Body Iron Stores
Description
Marker of iron status
Time Frame
Baseline and study end (8 weeks from baseline)
Secondary Outcome Measure Information:
Title
Frequency and severity of self-reported constipation
Time Frame
Study end (8 weeks from baseline)
Title
Frequency and severity of self-reported diarrhea
Time Frame
Study end (8 weeks from baseline)
Title
Frequency and severity of self-reported nausea
Time Frame
Study end (8 weeks from baseline)
Title
Frequency and severity of self-reported vomiting
Time Frame
Study end (8 weeks from baseline)
Title
Frequency and severity of self-reported fatigue
Time Frame
Baseline and study end (8 weeks from baseline)
Title
Self-reported energy level
Time Frame
Baseline and study end (8 weeks from baseline)
Title
Supplement compliance assessed using participant daily diary
Time Frame
Study end (8 weeks from baseline)
Title
Adverse events
Time Frame
Study end (8 weeks from baseline)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris D'Adamo, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Integrative Medicine University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29533710
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs