SupplementIRONNCT04199234
A Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market
A study testing Experimental product consumption and Comparator product consumption (Iron sulphate) in people with Supplement, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Supplement
- What is being tested?
- Experimental product consumption and Comparator product consumption (Iron sulphate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2020to 8 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Experimental product consumption, Comparator product consumption (Iron sulphate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental product consumptionDietary supplement
Consumption of an encapsulated iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch
Comparator product consumption (Iron sulphate)Dietary supplement
Consumption of iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 60 mg Encapsulated Iron Receives: Dietary Supplement: Experimental product consumption |
| control group | Active comparator | 60 mg Iron sulphate Receives: Dietary Supplement: Comparator product consumption (Iron sulphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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.
Measured: Day 1 and day 14 of each product consumption.
Saturated transferrin
Iron profile. By means of a blood draw.
Measured: Day 1 and day 14 of each product consumption.
Serum iron
Iron profile. By means of a blood draw.
Measured: Day 1 and day 14 of each product consumption.
Hemoglobin
Iron profile. By means of a blood draw.
Measured: 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)
Measured: Day 1 and day 14 of each product consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Feb 2020
- Primary completion23 Dec 2020
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SupplementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199234
- Sponsor's protocol ID
- UCAMCFE-0011
- Acronym
- IRON
- Status last verified
- Mar 2020
- First submitted
- 10 Dec 2019
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Crossover Study to Compare the Tolerability of Microencapsulated Iron Compared to a Conventional Iron Supplement in the Market
- ClinicalTrials.gov ID
- NCT04199234
- Acronym / sponsor ID
- IRON / UCAMCFE-0011
- Conditions
- Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: Experimental product consumption60 mg Encapsulated Iron |
| control group | Active comparator | Dietary Supplement: Comparator product consumption (Iron sulphate)60 mg Iron sulphate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental product consumptionConsumption of an encapsulated iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch | Dietary supplement | experimental group |
| Comparator product consumption (Iron sulphate)Consumption of iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch | Dietary supplement | control group |
Primary outcome
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.
19 secondary outcomes
Frequency of appearance of each 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.
Change in the total number of incidences/complaints related to the study product
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.
Number of clinical manifestations that subjects experience
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.
Overall intensity of clinical manifestations that subjects experience (nausea, heartburn, abdominal pain, gas/swelling)
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.
Overall intensity of clinical manifestations that subjects experience (diarrhea and vomits)
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.
Change in the acute intensity of adverse effects that subjects experience
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.
Duration (number of days) of clinical manifestation
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.
Duration (minutes per day) of clinical manifestation
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.
Health status using VAS scale
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.
Physical activity
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.
Bowel movements
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.
Stool morphology
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.
Sleep quality
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.
Sleep duration
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.
Ferritin
Time frame: Day 1 and day 14 of each product consumption.
Saturated transferrin
Time frame: Day 1 and day 14 of each product consumption.
Serum iron
Time frame: Day 1 and day 14 of each product consumption.
Hemoglobin
Time frame: Day 1 and day 14 of each product consumption.
Safety variables
Time frame: Day 1 and day 14 of each product consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental product consumption and Comparator product consumption (Iron sulphate) in people with Supplement, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.