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

Description

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.

A total of 82 premenopausal female subjects over the age of 18 years old are planned for this study. Enrolled subjects will be assigned a unique study number in the 100 series as the subject ID for the study to maintain anonymity. The subject ID will be assigned in sequential order starting with 101 (i.e., 101, 102, 103, etc). After signing the informed consent document, enrolled subjects will be screened, and qualifying subjects will be randomly assigned to one of two groups (Group A or Group B) depending on the treatment (liquid iron supplement or placebo). Following random assignment, subjects will revisit the laboratory to complete baseline testing for primary, secondary, and exploratory outcomes. After 4 weeks of daily supplementation of their respective randomly assigned condition, subjects return to the laboratory for reassessment of secondary outcomes. The last laboratory visit will occur following 8 weeks of daily supplementation in which subjects will be reassessed on all outcomes in a manner identical to baseline.

GROUPS

• Group A: Single-dose containing 10 mL of a liquid iron formulation to be ingested once a day on an empty stomach no sooner than 3 hours after consuming a meal.
• Group B: Single-dose containing 10 mL of the placebo formulation to be ingested once a day on an empty stomach no sooner than 3 hours after consuming a meal.

VISITS

• Visit 1: Study enrollment and eligibility screening. Written informed consent will be obtained to confirm study enrollment prior to eligibility screening.
• Visit 2: Baseline assessment
• Visit 3: Reassess secondary variables only
• Visit 4: Reassess all measurements for final post-testing and end of study (EOS).

For laboratory visits requiring blood donation (visits 1, 2, and 4), subjects will arrive at the laboratory following an overnight fast (≥ 10 hours) and undergo standard sterile venipuncture techniques by a certified phlebotomist. Blood samples, approximately 10mL in volume, will be collected into a marble top (gel-barrier) tube interiorly coated with silicone. Following collection, samples will be inverted 4-6 times then stored upright at room temperature in a test tube holder for approximately 30 minutes to promote coagulation; thereafter, samples will be centrifuged for serum separation. The resulting serum aliquot will be immediately stored at -80°C until further analysis of blood chemistry variables.

For questionnaire assessments (Patient assessment of constipation - symptoms, functional bowel index, Gastrointestinal symptom rating scale, and abbreviated Profile of Mood States), subjects will complete the questionnaires in isolation in a quiet room isolated to avoid bystander influence. For visit 3, subjects are not required to be fasted. All study visits will be conducted at the same time of day (± 1 hour).

Details