Efficacy of a Low Dose, Oral, Liquid Iron Supplement on Restoring Inadequate Blood Iron to Normal Levels
Assessment of the Efficacy of a Low-Dose Iron Supplement in Restoring Iron Levels to Normal Range Without Promoting Constipation or Adverse Gastrointestinal Effects Among Healthy Premenopausal Women With Iron Deficiency Without Anemia
1 other identifier
interventional
95
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2022
CompletedStudy Start
First participant enrolled
February 7, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2022
CompletedMay 30, 2023
May 1, 2023
10 months
February 4, 2022
May 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Serum Iron
Changes in Iron in fasted serum blood samples.
Week 0 and Week 8
Serum Ferritin
Changes in Ferritin in fasted serum blood samples.
Week 0 and Week 8
Total Iron-Binding Capacity (TIBC)
Changes in TIBC in fasted serum blood samples.
Week 0 and Week 8
Transferrin Saturation (tSAT)
Changes in tSAT in fasted serum blood samples.
Week 0 and Week 8
Complete Blood Count (CBC)
Changes in complete blood count with differential will be assessed via fasted serum blood samples
Week 0 and Week 8
High Sensitivity C-Reactive Protein (hs-CRP)
Changes in hs-CRP in fasted serum blood samples.
Week 0 and Week 8
Secondary Outcomes (5)
Patient Assessment of Constipation - Symptoms Questionnaire
Week 0, Week 4, and week 8
Functional Bowel Index
Week 0, Week 4, and week 8
Gastrointestinal symptom rating scale
Week 0, Week 4, and week 8
Abbreviated Profile of Mood States
Week 0 and Week 8
Adverse Events
Week 0, Week 4, and Week 8
Other Outcomes (2)
Body Composition via Body Fat Percentage
Week 0 and Week 8
Bone Mineral Density
Week 0 and Week 8
Study Arms (2)
Placebo
PLACEBO COMPARATORDaily dose (10 mL) of a visually identical liquid placebo supplement to be ingested on an empty stomach no sooner than 3 hours after consuming a meal.
Blood Builder Treatment
EXPERIMENTALDaily dose (10 mL) of liquid iron supplement (Blood Builder®) formulation to be ingested on an empty stomach no sooner than 3 hours after consuming a meal.
Interventions
8-weeks of supplementing with a visually identical liquid placebo supplement.
8-weeks of supplementing with a liquid iron supplement (Blood Builder ®)
Eligibility Criteria
You may qualify if:
- Healthy female subjects \> 18 years old
- Premenopausal (experiencing regular menstrual cycles)
- Hemoglobin \> 11g/dL
- Serum ferritin \< 70 ng/mL
- 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.
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Applied Science and Performance Institute
Tampa, Florida, 33607, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2022
First Posted
February 25, 2022
Study Start
February 7, 2022
Primary Completion
December 9, 2022
Study Completion
December 9, 2022
Last Updated
May 30, 2023
Record last verified: 2023-05