NCT04199234CompletedNot Applicable
A Randomized, Double Blind, Crossover Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market
Universidad Católica San Antonio de Murcia2 sites in 1 country48 target enrollmentStarted: February 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Frequency of appearance of the total clinical manifestations due to the consumption of both products
Study Overview
Brief Summary
The purpose of this study is to compare the frequency of appearance of the total clinical manifestations (expected adverse event: nausea, vomiting, heartburn, abdominal pain, gas/swelling, diarrhea, headache, shortness of breath, metallic taste and constipation) after consuming microencapsulated iron and comparator for 14 days.
Detailed Description
Subjects will consume a daily dose once per day for 14 days with a washout period of two menstrual cycles between the two products. After this washout period, subjects will return to the clinical and will undergo identical procedures with counter order of the intervention.
Each day of the study will be recorded in a diary by each subject. Participants will be requested not to change their regular life habits and diet during the entire study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy premenopausal women (Age: 18-50)
- •Not anemic
- •Normal Iron status: hemoglobin (>12 g/dL)
- •Normal BMI (20-25 kg/m²)
- •Normal blood profile at screening: Complete blood count, platelets, Glucose, HbA1c, Electrolytes (Na, K, Cl), AST, ALT, bilirubin, y-GT), Creatinine, eGFR, blood urea nitrogen, uric acid, Total protein (albumin/ globulin)
- •Subject is in good physical health as established by medical history, vital signs, physical examination and electrocardiogram (ECG)
- •Normal urine profile at screening: pH, protein, glucose, nitrite, ketone, bilirubin, urobilinogen, red blood cells, leukocytes, creatinine, sediments, absence of bacteria
- •Regular menstrual cycle (28 +/- 5)
- •Willingness not to change eating habits (do not start/ change of diet) and general habits (stop smoking) for the duration of the study
- •C-reactive protein: < 5mg/L.
Exclusion Criteria
- •Previous participation in iron tolerability trials.
- •Participation in a clinical research trial within 30 days prior to randomization
- •Chronic medication (except oral contraceptives)
- •Pregnancy or lactation
- •Hb levels < 12g/dL (women) (anemia)
- •Reported chronic disease
- •Infectious disease
- •Alcohol or drug abuse
- •Hyperlipidemia as defined by LDL > 3.36 mmol/L (130 mg/dL) and/or triglycerides > 2.26 mmol/L (200 mg/dL).
- •Relevant co-morbidities: Gastrointestinal disease such as peptic ulcer, enteritis, or ulcerative colitis, inflammation, pre-existing poorabsorption or liver disease, kidney disease, iron-storage disorders such as hemochromatosis, haemosiderosis, or chronic autoimmune inflammatory condition
- •Serious illness that may confound study results or interfere with compliance
- •Any other laboratory abnormality, medical condition or psychiatric disorder which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
- •Known intolerance to oral iron supplements
- •Intake of iron suppl. and/or multivitamins containing iron during the last three months before study entry
- •Use of any mineral/vitamin or other supplements during the past month prior to study
- •Subject has a known allergy to the test material's active or inactive ingredients
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Any active medical illness in last 48 h
- •Sexually-active females who are not willing to use an effective form of birth control.
- •Subjects with severe premenstrual symptoms (PMS)
- •Subjects that have followed specific diet, eg. high protein diet, within 30 days prior to study start
- •Previous gastric bypass, sleeve gastrectomy, or gastric band surgery
- •Blood donation within the previous 1 months.
Outcomes
Primary Outcomes
Frequency of appearance of the total clinical manifestations due to the consumption of both products
Time Frame: This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.
The proportion of participants that reported at least one adverse event, which refers to the total of clinical manifestations due to the consumption of both products. Symptoms that were considered: nausea, heartburn, abdominal pain, gas/swelling, diarrhea, vomits, metallic taste, constipation, headache and respiratory distress.
Secondary Outcomes
- Overall intensity of clinical manifestations that subjects experience (diarrhea and vomits)(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Bowel movements(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Serum iron(Day 1 and day 14 of each product consumption.)
- Safety variables(Day 1 and day 14 of each product consumption.)
- Frequency of appearance of each of the total clinical manifestations due to the consumption of both products(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Overall intensity of clinical manifestations that subjects experience (nausea, heartburn, abdominal pain, gas/swelling)(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Health status using VAS scale(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Physical activity(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Ferritin(Day 1 and day 14 of each product consumption.)
- Number of clinical manifestations that subjects experience(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Stool morphology(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Sleep quality(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Sleep duration(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Hemoglobin(Day 1 and day 14 of each product consumption.)
- Change in the total number of incidences/complaints related to the study product(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Duration (minutes per day) of clinical manifestation(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Change in the acute intensity of adverse effects that subjects experience(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Duration (number of days) of clinical manifestation(This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period.)
- Saturated transferrin(Day 1 and day 14 of each product consumption.)
Investigators
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia
Study Sites (2)
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