A Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market (IRON)

Universidad Católica San Antonio de Murcia

Status

Completed

Conditions

Supplement

Treatments

Dietary Supplement: Comparator product consumption (Iron sulphate)

Dietary Supplement: Experimental product consumption

Study type

Interventional

Funder types

Other

Identifiers

NCT04199234

UCAMCFE-0011

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.