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

NCT ID: NCT04199234

Last Updated: 2021-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-03-08

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.

Conditions

Supplement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

experimental group

60 mg Encapsulated Iron

Group Type: EXPERIMENTAL

Experimental product consumption

Intervention Type: DIETARY_SUPPLEMENT

Consumption of an encapsulated iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch

control group

60 mg Iron sulphate

Group Type: ACTIVE_COMPARATOR

Comparator product consumption (Iron sulphate)

Intervention Type: DIETARY_SUPPLEMENT

Consumption of iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch

Interventions

Experimental product consumption

Consumption of an encapsulated iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch

Intervention Type: DIETARY_SUPPLEMENT

Comparator product consumption (Iron sulphate)

Consumption of iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier López Román

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

UCAMCFE-0011

Identifier Type: -

Identifier Source: org_study_id