NCT05185024

Daily Oral Iron Supplementation for Replenishment of Depleted Iron in Adults

A Study of Efficacy and Safety of Three Different Oral Iron-Containing Dietary Supplements in Correction of Hematological Indices and Replenishment of Depleted Iron Stores in Iron Deficient Adults With or Without Mild Microcytic Anemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: PharmaLinea Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The study is designed as a parallel, randomized, double blind, three-arm single-center study exploring the efficacy and safety of 12-week once daily oral dosing of iron for correction of overall iron status in 150 otherwise healthy iron-deficient adults presenting with or without mild microcytic anemia. Three iron-containing preparations in the form of either Ferrous Sulfate Capsules, \>Your\< Iron Forte Capsules, or \>Your\< Iron Forte Liquid will be tested. Potential study participants will be recruited from the general population of 18-50 year old adults. Participant eligibility will be determined by screening for hemoglobin and ferritin (in combination with C-reactive protein) levels in a sample of venous blood. Eligible individuals will be invited to participate in the study. Enrolled participants will be randomized into one of three intervention groups in a 1:1:1 ratio, receiving either Ferrous Sulfate Capsules, \>Your\< Iron Forte Capsules, or \>Your\< Iron Forte Liquid. Efficacy and safety of the assigned interventions will be evaluated through analyses of relevant hematological (hemoglobin, red blood cell indices) and biochemical (ferritin, transferrin saturation) iron-related parameters and reported adverse events after the first 4 and after a total of 12 weeks of intervention.

Conditions

• Iron-deficiency
• Iron Deficiency Anemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ferrous Sulfate Capsules	Once daily dose of one Ferrous Sulfate Capsule for 12 weeks in total.
DIETARY_SUPPLEMENT	>Your< Iron Forte Capsules	Once daily dose of one \>Your\< Iron Forte Capsule for 12 weeks in total.
DIETARY_SUPPLEMENT	>Your< Iron Forte Liquid	Once daily dose of 5 ml of \>Your\< Iron Forte Liquid for 12 weeks in total.
OTHER	Blank Capsules	Once daily dose of one Blank Capsule (excipients only) for 12 weeks in total.
OTHER	Blank Liquid	Once daily dose of 5 ml of Blank Liquid (excipients only) for 12 weeks in total.

Timeline

• Start date: 2022-01-19
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2022-01-11
• Last updated: 2024-03-29

Locations

1 site across 1 country: Slovenia