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Completed

NCT Number: NCT02683369

Low-dose Iron Supplementation and Markers of Iron Status Among 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.

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Key information

Conditions

Non-anemic Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Center for Integrative Medicine University of Maryland

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Low-dose iron dietary supplement

Primary outcomes

  1. Changes in Hemoglobin (Hgb) Level

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

    Marker of iron status

  2. Changes in Serum Ferritin (SF) Level

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

    Marker of iron status

  3. Changes in Soluble Transferrin Receptor (sTfR) Level

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

    Marker of iron status

  4. Changes in Total Body Iron Stores

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

    Marker of iron status

Secondary outcomes

  1. Frequency and severity of self-reported constipation

    Time frame: Study end (8 weeks from baseline)

  2. Frequency and severity of self-reported diarrhea

    Time frame: Study end (8 weeks from baseline)

  3. Frequency and severity of self-reported nausea

    Time frame: Study end (8 weeks from baseline)

  4. Frequency and severity of self-reported vomiting

    Time frame: Study end (8 weeks from baseline)

  5. Frequency and severity of self-reported fatigue

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

  6. Self-reported energy level

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

  7. Supplement compliance assessed using participant daily diary

    Time frame: Study end (8 weeks from baseline)

  8. Adverse events

    Time frame: Study end (8 weeks from baseline)

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2016
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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