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

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    82
  • sponsor
    Applied Science & Performance Institute
Updated on 10 March 2022
Accepts healthy volunteers

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.

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
Condition Iron Deficiency (Without Anemia)
Treatment Liquid Placebo Supplementation, Liquid Iron Supplement (Blood Builder ®)
Clinical Study IdentifierNCT05257343
SponsorApplied Science & Performance Institute
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy female subjects > 18 years old
Premenopausal (experiencing regular menstrual cycles)
Non-anemic iron deficiency (defined as: hemoglobin > 11g/dL, serum ferritin < 40 ng/mL, and tSAT < 20%)
hs-CRP < 3 mg/L
BMI 18 - 29.9 kg/m2
No intake of dietary supplements containing iron 30 days prior to enrollment
Willing and able to give written informed consent
Able to read, understand, sign and date the informed consent document (English only)
Able and willing to comply with the schedule visit(s) and study requirements

Exclusion Criteria

Currently taking (within the past 14 days) dietary supplements including, vitamins (any), minerals, protein shakes, vitamin water, other supplements
History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements, (i.e., inflammatory bowel disease, ulcerative colitis, Crohn's disease, colostomy, or eating disorder)
History or current malignancy
Receiving chemotherapy agents or radiation treatments
Prior health issues showing high CRP or other inflammatory markers
Pregnancy or has breast fed within 3 months prior to enrollment
BMI <18 or >25 kg/m2
Diagnosis of a terminal illness
Use of prescription medications that impact digestion (i.e., proton pump inhibitor medications, other)
History of alcohol abuse
History or current drug abuse
History or current cigarette smoke (including vaping) within the past 14 days from the screening visit
Insulin-dependent diabetes and/or metformin use
Chronic kidney or liver disease
Anemia
Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other, which in the opinion of the investigator, such condition might be aggravated as a result of treatment
The investigator feels that for any reason the subject is not eligible to participate in the study
Use within 24 hours preceding enrollment of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia)
History of uncontrolled cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
History, or current bleeding disorders (i.e., hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants
Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements
A family member of the investigator or an employee of the investigator
Participation in any other investigational study within 30 days prior to consent
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