Iron DeficiencyNCT02572128
Mineral Absorption From Fortified Rice Produced With Different Fortification Techniques
A study testing Fortified rice in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 2 sites in Switzerland.
Trial summary
The investigators studies will compare iron, respectively iron and zinc bioavailability from fortified rice produced from different fortification techniques using stable isotopic labels. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Fortified rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jun 2015to Dec 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 18 to 45 years old
- Normal body Mass Index (18.5 - 25 kg/m2)
- Body weight < 65 kg
- Signed informed consent
Who cannot join
- Pregnancy (assessed by a pregnancy test) or intention to become pregnant during the study
- Lactating/ Breastfeeding
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole study (except for contraceptives)
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration and during the intervention time
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months and during the intervention time
Show all 10Show fewer
- Earlier participation in a study using Fe or Zn stable isotopes or participation in any clinical study within the last 30 days
- Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)
- Smoking
- Vegan diet
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Clinical Trials Center, University Hospital
Zurich, Canton of Zurich, 8091
Human Nutrition Laboratory, ETH Zurich
Zurich, 8092
About this study
Official title: Comparative Evaluations of Micronutrient Absorption From Mineral Fortified Rice Produced With Different Fortification Techniques: An Evaluation of Hot and Cold Extrusion (Study 1) and Coating Technologies (Study 2)
The investigators studies will compare iron, respectively iron and zinc bioavailability from fortified rice produced from different fortification techniques using stable isotopic labels. Study 1 aims to compare the iron bioavailability from hot and cold extruded rice, in Study 2 the iron and zinc bioavailability from rice using one coating technique and hot extrusion will be compared.
Read the detailed description
Both studies will have a randomized single-blind, cross-over design. Study 1 will be conducted at the Institute for Nutrition and Health (IFNH), Swiss Federal Institute of Technology (ETH) Zurich exclusively; Study 2 will be conducted partly at Clinical Trials Center (CTC) Zurich and at Institute for Nutrition and Health (IFNH).
Study 1: From an initial screening of interested candidates, the investigators will include 20 participants to participate in the study. The participants will consume two different test meals containing 48g regular Basmati rice and 2g fortified rice with a vegetable sauce (in a random order as defined in the study plan). The meals will be based on fortified rice fortified with 57FePP, ZnO and a micronutrient mix, produced with hot (meal A) or cold (meal B) extrusion. The micronutrient mix will contain per served meal 170 µg Folic acid, 1.3 µg vitamin B12, 0.195 mg Vitamin A, 0.65 mg thiamin, 9.1 mg niacin, 0.78 mg vitamin B6 (17) as well as 1,26 mg citric acid and 36,16 mg trisodium-citrate serving as an enhancer for iron absorption. Randomization will include the random order of test meal A and B. Stable iron isotopes will be incorporated in the fortified rice.
The whole study duration from the screening to the last contact with the participant will be about 1 month (36 days, including screening). At screening, on the days of test meal administration and at the study endpoint visit, the participants will spend about 30 minutes at the IFNH in the morning (0700 - 0900h).
Study 2: From an initial screening of interested candidates, 24 non-pregnant non-lactating women will be recruited. The participants will be randomly assigned to one of 3 cohorts (1, 2, 3). The only differences between the cohorts will be the time of study-start and the time of reference meal administration. The participants will consume two different test meals (in a random order as defined in the study plan) and one reference meal. The meals will be based on rice fortified with stable isotopes of iron (57FePP) and zinc (67ZnO) as well as a micronutrient mix, produced with coated rice from Wright Enrichment Inc. (meal A) or hot extruded rice produced at ETH Zurich (meal B). The reference meal (meal C) will consist of extruded rice with the micronutrient mix only (with no extra added iron or zinc) and regular rice where a 58FeSO4 (Ferrous Sulfate) solution is added prior to consumption. Randomization will include the random order of test meals A and B. Meal C will be given one day before the first (cohort 1) or second (cohort 2) test meal. Additionally, stable zinc isotopes will be given to the subjects intravenously.
The whole study duration from the screening to the last contact with the participant will be about 2 months (51 days including screening). At screening and on the days of test meal administration, the participants will spend about 20 - 30 minutes at the IFNH or at the CTC in the morning (0700 - 0900h).
For both studies, the blood samples will be used for determining iron bioavailability. In Study 2, additional urine samples will be collected for determining the zinc bioavailability. The baseline blood and urine samples and the blood samples collected 14 days (Study 1), respectively 15 days (Study 2), after test meal administration as well as the urine samples collected 4 days (96 hours) after test meal administration will be analyzed by inductively coupled plasma mass spectrometry (ICP-MS) for isotope enrichment, and fractional as well as absolute Fe and Zn absorption will be calculated for each test meal in each subject.
- Conditions
- Iron Deficiency
- Being tested
- Fortified rice
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified riceOther
Study 1: Hot or cold extruded rice fortified test meals fortified with Ferric Pyrophosphate and Zinc oxide will be administered - subjects serve as their own controls.
Study 2: Hot extruded rice or coated rice fortified with Ferric Pyrophosphate and Zinc Oxide will be administered.
Regular rice fortified with Ferrous Sulfate (FeSO4) will act as a control in study 2.
| Study group | Role | What they receive |
|---|---|---|
| Study 1 | Experimental | Iron fortified rice hot or cold extruded. Receives: Other: Fortified rice |
| Study 2 | Experimental | Iron and zinc fortified rice hot extruded or coated. Receives: Other: Fortified rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1: Fractional iron absorption;
Fractional iron (Study 1 and 2) absorption from different isotopically labelled meals will be calculated based on the shift of the isotope ratios in collected blood (for iron determination) samples. The iron absorption will be assessed from blood samples collected 14 or 15 days after meal administration. Iron isotope ratios will be determined by mass spectrometry. Total absorbed iron: measurement unit = mg; Fractional absorbed zinc: measurement unit = %
Measured: 6 months
Study 2: Additionally fractional Zinc absorption
Fractional zinc (Study 2) absorption from different isotopically labelled meals will be calculated based on the shift of the isotope ratios in collected urine (for zinc determination) samples. The zinc absorption will be assessed from urine samples collected 4 days after meal administration. Zinc isotope ratios will be determined by mass spectrometry. Total absorbed zinc: measurement unit = mg; Fractional absorbed zinc: measurement unit = %
Measured: 3 months
Secondary outcomes (4)
Hemoglobin
The secondary outcomes in both studies are the assessment of haemoglobin, plasma ferritin and c-reactive protein in the participants. Unit: mg/l
Measured: 6 months
Plasma Ferritin
The secondary outcomes in both studies are the assessment of haemoglobin, plasma ferritin and c-reactive protein in the participants. Unit: mg/l
Measured: 6 months
C- Reactive Protein
The secondary outcomes in both studies are the assessment of haemoglobin, plasma ferritin and c-reactive protein in the participants. Unit: mg/l
Measured: 6 months
Plasma Zinc
This secondary outcome will be assessed in study 2 only. Unit: mg/l
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- United Nations World Food Programme (WFP), Global Alliance for Improved Nutrition
- Responsible party
- Sponsor
- Investigators
- Michael Zimmermann, Prof. Dr., Principal investigator, Head of Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572128
- Sponsor's protocol ID
- Rice_FeZnEC
- Status last verified
- Jul 2016
- First submitted
- 15 Apr 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluations of Micronutrient Absorption From Mineral Fortified Rice Produced With Different Fortification Techniques: An Evaluation of Hot and Cold Extrusion (Study 1) and Coating Technologies (Study 2)
- ClinicalTrials.gov ID
- NCT02572128
- Acronym / sponsor ID
- Rice_FeZnEC
- Conditions
- Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- United Nations World Food Programme (WFP), Global Alliance for Improved Nutrition
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Oct 2015 (estimated)
- 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 investigators studies will compare iron, respectively iron and zinc bioavailability from fortified rice produced from different fortification techniques using stable isotopic labels. Study 1 aims to compare the iron bioavailability from hot and cold extruded rice, in Study 2 the iron and zinc bioavailability from rice using one coating technique and hot extrusion will be compared.
Detailed description
Both studies will have a randomized single-blind, cross-over design. Study 1 will be conducted at the Institute for Nutrition and Health (IFNH), Swiss Federal Institute of Technology (ETH) Zurich exclusively; Study 2 will be conducted partly at Clinical Trials Center (CTC) Zurich and at Institute for Nutrition and Health (IFNH).
Study 1: From an initial screening of interested candidates, the investigators will include 20 participants to participate in the study. The participants will consume two different test meals containing 48g regular Basmati rice and 2g fortified rice with a vegetable sauce (in a random order as defined in the study plan). The meals will be based on fortified rice fortified with 57FePP, ZnO and a micronutrient mix, produced with hot (meal A) or cold (meal B) extrusion. The micronutrient mix will contain per served meal 170 µg Folic acid, 1.3 µg vitamin B12, 0.195 mg Vitamin A, 0.65 mg thiamin, 9.1 mg niacin, 0.78 mg vitamin B6 (17) as well as 1,26 mg citric acid and 36,16 mg trisodium-citrate serving as an enhancer for iron absorption. Randomization will include the random order of test meal A and B. Stable iron isotopes will be incorporated in the fortified rice.
The whole study duration from the screening to the last contact with the participant will be about 1 month (36 days, including screening). At screening, on the days of test meal administration and at the study endpoint visit, the participants will spend about 30 minutes at the IFNH in the morning (0700 - 0900h).
Study 2: From an initial screening of interested candidates, 24 non-pregnant non-lactating women will be recruited. The participants will be randomly assigned to one of 3 cohorts (1, 2, 3). The only differences between the cohorts will be the time of study-start and the time of reference meal administration. The participants will consume two different test meals (in a random order as defined in the study plan) and one reference meal. The meals will be based on rice fortified with stable isotopes of iron (57FePP) and zinc (67ZnO) as well as a micronutrient mix, produced with coated rice from Wright Enrichment Inc. (meal A) or hot extruded rice produced at ETH Zurich (meal B). The reference meal (meal C) will consist of extruded rice with the micronutrient mix only (with no extra added iron or zinc) and regular rice where a 58FeSO4 (Ferrous Sulfate) solution is added prior to consumption. Randomization will include the random order of test meals A and B. Meal C will be given one day before the first (cohort 1) or second (cohort 2) test meal. Additionally, stable zinc isotopes will be given to the subjects intravenously.
The whole study duration from the screening to the last contact with the participant will be about 2 months (51 days including screening). At screening and on the days of test meal administration, the participants will spend about 20 - 30 minutes at the IFNH or at the CTC in the morning (0700 - 0900h).
For both studies, the blood samples will be used for determining iron bioavailability. In Study 2, additional urine samples will be collected for determining the zinc bioavailability. The baseline blood and urine samples and the blood samples collected 14 days (Study 1), respectively 15 days (Study 2), after test meal administration as well as the urine samples collected 4 days (96 hours) after test meal administration will be analyzed by inductively coupled plasma mass spectrometry (ICP-MS) for isotope enrichment, and fractional as well as absolute Fe and Zn absorption will be calculated for each test meal in each subject.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study 1 | Experimental | Other: Fortified riceIron fortified rice hot or cold extruded. |
| Study 2 | Experimental | Other: Fortified riceIron and zinc fortified rice hot extruded or coated. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, 18 to 45 years old
- Normal body Mass Index (18.5 - 25 kg/m2)
- Body weight < 65 kg
- Signed informed consent
Key exclusion criteria (10 listed)
- Pregnancy (assessed by a pregnancy test) or intention to become pregnant during the study
- Lactating/ Breastfeeding
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole study (except for contraceptives)
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration and during the intervention time
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 |
|---|---|---|
| Fortified riceStudy 1: Hot or cold extruded rice fortified test meals fortified with Ferric Pyrophosphate and Zinc oxide will be administered - subjects serve as their own controls. Study 2: Hot extruded rice or coated rice fortified with Ferric Pyrophosphate and Zinc Oxide will be administered. Regular rice fortified with Ferrous Sulfate (FeSO4) will act as a control in study 2. | Other | Study 1, Study 2 |
Primary outcome
Study 1: Fractional iron absorption;
Time frame: 6 months
Fractional iron (Study 1 and 2) absorption from different isotopically labelled meals will be calculated based on the shift of the isotope ratios in collected blood (for iron determination) samples. The iron absorption will be assessed from blood samples collected 14 or 15 days after meal administration. Iron isotope ratios will be determined by mass spectrometry. Total absorbed iron: measurement unit = mg; Fractional absorbed zinc: measurement unit = %
Study 2: Additionally fractional Zinc absorption
Time frame: 3 months
Fractional zinc (Study 2) absorption from different isotopically labelled meals will be calculated based on the shift of the isotope ratios in collected urine (for zinc determination) samples. The zinc absorption will be assessed from urine samples collected 4 days after meal administration. Zinc isotope ratios will be determined by mass spectrometry. Total absorbed zinc: measurement unit = mg; Fractional absorbed zinc: measurement unit = %
4 secondary outcomes
Hemoglobin
Time frame: 6 months
Plasma Ferritin
Time frame: 6 months
C- Reactive Protein
Time frame: 6 months
Plasma Zinc
Time frame: 6 months
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 12 Jul 2016.
Related trials for Iron Deficiency
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Not yet recruitingPhase 4
Iron Repletion in Cystic Fibrosis
Cystic Fibrosis, Iron Deficiencies
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
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.
Michael Zimmermann, Prof. Dr. principal investigator
Head of Laboratory
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified rice in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 2 sites in Switzerland.
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 4 inclusion and 10 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Study 1: Fractional iron absorption; (time frame: 6 months). The study lists 2 primary outcomes in all. 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 12 Jul 2016; AzTrials last refreshed its copy on 2 Nov 2026.