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

NCT ID: NCT02683369

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-05-31

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.

Conditions

Non-anemic Iron Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iron Supplement

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

Group Type: EXPERIMENTAL

Blood Builder®/Iron Response®

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Low-dose iron dietary supplement

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Chris D'Adamo

Director of Research Center for Integrative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris D'Adamo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

Center for Integrative Medicine University of Maryland

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29533710 (View on PubMed)

Other Identifiers

017-FS; HP-00067251

Identifier Type: -

Identifier Source: org_study_id