Completed

Impact of Low-Dose Iron Supplement on Iron Status in Iron-Deficient Premenopausal Women

What is being tested

Blood Builder®/Iron Response®

Dietary Supplement

Who is being recruted

Iron Deficiencies+1

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 55 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: February 2016

See protocol details

Summary

Principal SponsorUniversity of Maryland, Baltimore

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2016

Actual date on which the first participant was enrolled.

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 TitleEffects of a Commercially-available, Low-dose Iron Supplement (BloodBuilder®/Iron Response®) on Markers of Iron Status Among Premenopausal and Non-anemic, Iron-deficient Women

NCT02683369

Principal SponsorUniversity of Maryland, Baltimore

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Iron DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesIron Metabolism Disorders

Criteria

5 inclusion criteria required to participate

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

Show More Criteria

8 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Center for Integrative Medicine University of Maryland

Baltimore, United StatesOpen Center for Integrative Medicine University of Maryland in Google Maps

CompletedOne Study Center