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

Non-anemic Iron Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683369
• Other study ID #: 017-FS; HP-00067251
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2016
• Est. completion date: May 2017

Study information

• Verified date: August 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Non-anemic Iron Deficiency

Intervention

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

Locations

Country	Name	City	State
United States	Center for Integrative Medicine University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Hemoglobin (Hgb) Level	Marker of iron status	Baseline and study end (8 weeks from baseline)
Primary	Changes in Serum Ferritin (SF) Level	Marker of iron status	Baseline and study end (8 weeks from baseline)
Primary	Changes in Soluble Transferrin Receptor (sTfR) Level	Marker of iron status	Baseline and study end (8 weeks from baseline)
Primary	Changes in Total Body Iron Stores	Marker of iron status	Baseline and study end (8 weeks from baseline)
Secondary	Frequency and severity of self-reported constipation		Study end (8 weeks from baseline)
Secondary	Frequency and severity of self-reported diarrhea		Study end (8 weeks from baseline)
Secondary	Frequency and severity of self-reported nausea		Study end (8 weeks from baseline)
Secondary	Frequency and severity of self-reported vomiting		Study end (8 weeks from baseline)
Secondary	Frequency and severity of self-reported fatigue		Baseline and study end (8 weeks from baseline)
Secondary	Self-reported energy level		Baseline and study end (8 weeks from baseline)
Secondary	Supplement compliance assessed using participant daily diary		Study end (8 weeks from baseline)
Secondary	Adverse events		Study end (8 weeks from baseline)