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

A Randomized, Double Blind, Crossover Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market

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.

Study Overview

• Status: Completed
• Conditions: Supplement
• Intervention / Treatment: Dietary supplement: Experimental product consumption; Dietary supplement: Comparator product consumption (Iron sulphate)

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental group; 60 mg Encapsulated Iron	Dietary supplement: Experimental product consumption; Consumption of an encapsulated iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch
ACTIVE_COMPARATOR: control group; 60 mg Iron sulphate	Dietary supplement: Comparator product consumption (Iron sulphate); Consumption of iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of appearance of the total clinical manifestations due to the consumption of both products	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of appearance of each of the total clinical manifestations due to the consumption of both products	The proportion of participants that reported at least one adverse event, which refers to each of the total of clinical manifestations due to the consumption of both products (individual symptoms that were considered: nausea, heartburn, abdominal pain, gas/swelling, diarrhea, vomits, metallic taste, constipation, headache and respiratory distress)	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 total number of incidences/complaints related to the study product	Symptoms: nausea, heartburn, abdominal pain, gas/swelling, diarrhea, vomits, metallic taste, constipation, headache, and respiratory distress	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.
Number of clinical manifestations that subjects experience	Symptoms: nausea, heartburn, abdominal pain, gas/swelling, diarrhea, vomits, metallic taste, constipation, headache, and respiratory distress	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)	Intensity was measured with 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.
Overall intensity of clinical manifestations that subjects experience (diarrhea and vomits)	Intensity was measured with number of times.	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	Symptoms: Nausea, heartburn, abdominal pain, gas/swelling, vomits, diarrhea, constipation, metallic taste, headache, and respiratory distress	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 was measured in total duration (number of days) of symptom onset (symptoms: nausea, heartburn, abdominal pain, metallic taste, headache, diarrhea, constipation, gas/swelling, respiratory distress 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.
Duration (minutes per day) of clinical manifestation	Daily duration (minutes) of symptom (nausea, heartburn, abdominal pain, gas, metallic taste, headache, and respiratory distress)	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	Health status (daily and with respect to the previous day)	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	Proportion of participants that experienced any impact on daily 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.
Bowel movements	Number of times subjects go to the toilet.	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	Stool type (Bristol 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.
Sleep quality	Sleep quality measured on a scale of 1 to 5 (1 being poor sleep quality and 5 being very good 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	Number of hours subjects sleep	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	Iron profile. By means of a blood draw.	Day 1 and day 14 of each product consumption.
Saturated transferrin	Iron profile. By means of a blood draw.	Day 1 and day 14 of each product consumption.
Serum iron	Iron profile. By means of a blood draw.	Day 1 and day 14 of each product consumption.
Hemoglobin	Iron profile. By means of a blood draw.	Day 1 and day 14 of each product consumption.
Safety variables	Safety parameters (physical examination, vital signs, blood and urine laboratory tests, adverse events other than expected in the study)	Day 1 and day 14 of each product consumption.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2020
• Primary Completion (ACTUAL): December 23, 2020
• Study Completion (ACTUAL): March 8, 2021

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: UCAMCFE-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No