NCT02683369

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2016-02-17
• Last updated: 2019-08-16

Locations

1 site across 1 country: United States