Iron Deficiency (Without Anemia) Clinical Trial
Official title:
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
Verified date | May 2023 |
Source | Applied Science & Performance Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | December 9, 2022 |
Est. primary completion date | December 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Applied Science and Performance Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Applied Science & Performance Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Body Composition via Body Fat Percentage | Changes assessed in body fat percentage via Dual X-Ray Absorptiometry. | Week 0 and Week 8 | |
Other | Bone Mineral Density | Changes assessed in bone mineral density in grams via Dual X-Ray Absorptiometry. | Week 0 and Week 8 | |
Primary | Serum Iron | Changes in Iron in fasted serum blood samples. | Week 0 and Week 8 | |
Primary | Serum Ferritin | Changes in Ferritin in fasted serum blood samples. | Week 0 and Week 8 | |
Primary | Total Iron-Binding Capacity (TIBC) | Changes in TIBC in fasted serum blood samples. | Week 0 and Week 8 | |
Primary | Transferrin Saturation (tSAT) | Changes in tSAT in fasted serum blood samples. | Week 0 and Week 8 | |
Primary | Complete Blood Count (CBC) | Changes in complete blood count with differential will be assessed via fasted serum blood samples | Week 0 and Week 8 | |
Primary | High Sensitivity C-Reactive Protein (hs-CRP) | Changes in hs-CRP in fasted serum blood samples. | Week 0 and Week 8 | |
Secondary | Patient Assessment of Constipation - Symptoms Questionnaire | Changes assessed by administering the Patient Assessment of Constipation - Symptoms questionnaire for subjective assessment of constipation symptoms. Each question is answered from 0 (no symptoms at all) to 4 (severe symptoms). The lower the mean score, the less severe the symptoms. The higher the mean score, the more severe the symptoms. | Week 0, Week 4, and week 8 | |
Secondary | Functional Bowel Index | Changes assessed by administering the Functional Bowel Index for subjective assessment of bowel movements. A 3 item questionnaire scored from 0-100 with higher scores indicating greater severity and scores higher than 28.8 points indicating constipation. | Week 0, Week 4, and week 8 | |
Secondary | Gastrointestinal symptom rating scale | Changes assessed by administering the Gastrointestinal Symptom Rating Scale for subjective assessment of gastrointestinal symptoms and their severity. It is a 15-item questionnaire designed to assess the symptoms associated with common GI disorders. It has 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). Subscale scores range from 1 to 7 and higher scores represent more discomfort, and lower scores represent less or even no discomfort. | Week 0, Week 4, and week 8 | |
Secondary | Abbreviated Profile of Mood States | Changes assessed in the abbreviated profile of mood states for subjective assessment of the subject's mood and overall well-being. It is a 40 point scale, divided into 7 different subscales, with a 5 point Likert scale, ranging from 0 (not at all) to 4 (Extremely) of how a subject feels in response to that particular feeling. The following equation is used to determine the overall score: Total Mood Disturbance = [Tension+Depression+Anger+Fatigue+Confusion] - [Vigor+Esteem Related Affect]. A lower score indicates overall better mood, while a lower score indicates worse overall mood. | Week 0 and Week 8 | |
Secondary | Adverse Events | Defined as participants self-reported adverse effects. Items that will be surveyed are headache, dizziness, nausea, vomiting, indigestion, blurred vision, lethargy, swelling, itching, chest pain, heart palpitations, difficulty breathing, lethargy, and muscle cramps. | Week 0, Week 4, and Week 8 |
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