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

NCT04199234 | Completed

• 1 other identifier: UCAMCFE-0011
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

experimental group

EXPERIMENTAL

60 mg Encapsulated Iron

Dietary Supplement: Experimental product consumption

control group

ACTIVE COMPARATOR

60 mg Iron sulphate

Dietary Supplement: Comparator product consumption (Iron sulphate)

Interventions

Experimental product consumption DIETARY_SUPPLEMENT

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

experimental group

Comparator product consumption (Iron sulphate) DIETARY_SUPPLEMENT

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

control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Iron-Dextran Complex

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: February 1, 2020
• Primary Completion: December 23, 2020
• Study Completion: March 8, 2021
• Last Updated: July 26, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)