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

NCT02683369 | Completed Phase 2

• 1 other identifier: 017-FS; HP-00067251
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-anemic Iron Deficiency

Keywords

Non-anemic Iron Deficiency, Iron Supplementation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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)

Study Arms (1)

Iron Supplement

EXPERIMENTAL

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

Dietary Supplement: Blood Builder®/Iron Response®

Interventions

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

Also known as: Low-dose iron dietary supplement

Iron Supplement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Center for Integrative Medicine University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 29533710 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chris D'Adamo, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Center for Integrative Medicine

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 17, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

US (1)