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

University of Maryland Baltimore (UMB)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-anemic Iron Deficiency

Treatments: Dietary Supplement: Blood Builder®/Iron Response®

Study type: Interventional

Funder types: Other

Identifiers

NCT02683369

017-FS HP-00067251;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Iron Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Blood Builder®/Iron Response®