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Efficacy of a Low Dose, Oral, Liquid Iron Supplement on Restoring Inadequate Blood Iron to Normal Levels

NCT05257343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-05-30

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting constipating side-effects among healthy premenopausal women with non-anemic iron deficiency. The primary outcomes will be an Iron Panel of Serum Iron, Ferritin, Total iron-binding capacity, Transferrin saturation, Complete Blood Count, and high sensitivity - C-Reactive Protein. Secondary outcomes will be surveys on gastrointestinal distress/discomfort and well-being. Adverse events will also be reported.

Conditions

  • Iron Deficiency (Without Anemia)

Interventions

DIETARY_SUPPLEMENT

Liquid Placebo Supplementation

8-weeks of supplementing with a visually identical liquid placebo supplement.

DIETARY_SUPPLEMENT

Liquid Iron Supplement (Blood Builder ®)

8-weeks of supplementing with a liquid iron supplement (Blood Builder ®)

Sponsors & Collaborators

  • Applied Science & Performance Institute

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2022-12-09
Completion
2022-12-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257343 on ClinicalTrials.gov