AnemiaNCT03573570
Reducing Anemia Through Food Fortification at Scale
A study testing Fortified rice kernels in people with Anemia, run by Stanford University at 1 site in India.
Trial summary
Anemia is the most common form of malnutrition, affecting approximately 1.6 billion people world-wide. Most commonly caused by iron deficiency, its adverse effects include increased mortality (especially during childbirth), impaired cognitive development among children, chronic fatigue, and reduced lifetime earnings. Read more about this study
- Who is it for?
- Ages 6 months to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Fortified rice kernels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2018to 30 Sep 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 6 months to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children in the age group of 6 months to 5 years
- Women in the age group of 12 to 40 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
India1 site
Institute for Financial Management and Research (IFMR) and Cuddalore district, Tamil Nadu
Chennai, Tamil Nadu, 600006
About this study
Anemia is the most common form of malnutrition, affecting approximately 1.6 billion people world-wide. Most commonly caused by iron deficiency, its adverse effects include increased mortality (especially during childbirth), impaired cognitive development among children, chronic fatigue, and reduced lifetime earnings. While iron deficiency is the main cause of anemia worldwide, its etiology is complex and it can also be caused by an insufficient intake of other micronutrients such as Vitamin A, B9, B12 and folate as well as by helminthic infections and malaria.
Research in India and elsewhere has shown that under ideal (controlled) conditions, anemia can be reduced by consumption of iron-fortified food and other micro-nutrients. However, much less is known about the effectiveness of such interventions under actual program conditions on a large scale. This trial proposes to address anemia and other micronutrient deficiencies by providing micronutrient fortified rice through the Public Distribution System (PDS) of Tamil Nadu in a manner that requires no change in behaviour by end-user households and that can feasibly be conducted on a large scale.
This trial is designed as a rigorous cluster-randomized controlled trial with the full collaboration of the government of Tamil Nadu. The trial will follow a randomized cluster design at the Fair Price Shops (FPS) which distribute rice in the Tamil Nadu PDS. Fair Price Shops will be assigned randomly either to the treatment or the control arm, and will either be provided fortified rice for distribution, or the standard, non-fortified rice.
Read the detailed description
The proposed project will leverage the existing state-run public distribution system (PDS) to provide fortified rice using a domestically manufactured rice grain (Fortified Rice Kernels, or FRK). FRKs are grains made from rice flour, highly enriched with iron and other micronutrients (such as Vitamin A, B9 and Vitamin B12), and shaped like a conventional grain of rice. It is mixed into conventional rice in specified ratios (1g of FRK 100g of conventional rice) and is almost indistinguishable from conventional rice in appearance and taste. For this study, rice will be fortified using FRKs containing iron, zinc, vitamin A and vitamins B1, B3, B6, B9 and B12.
The Tamil Nadu PDS already provides up to 20 kilograms of rice at no cost to all households in the state, with an additional 15 kilograms to households identified as particularly poor. This is done through a widespread network of Fair Price Shops (FPS). The proposed study (implementation and accompanying evaluation) will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12-15 months apart. In the interim, 110 Treatment FPS will be randomly assigned to receive fortified rice, and another 110 randomly assigned Control FPS will continue receiving conventional rice. The investigators plan to conduct the study in one sub-district of Tamil Nadu with a population of about 1/2 million people.
In a cluster, the study team will randomly select 40 households to participate in the baseline and followup surveys and household members meeting the eligibility criteria, i.e. women between 12 and 40 years and children between 6 and 59 months, will be enrolled. These surveys will collect information about dietary patterns and socioeconomic status, and importantly, will also collect objectively measured health indicators (biomarkers and anthropometric measures), to test directly for anemia and micronutrient deficiencies.
To implement the intervention, the Government pre-existing PDS system, will be used. Every household in Tamil Nadu has a card that entitles it monthly to a pre-specified quantity of rice (and other goods) from a specific location that belongs to a network of so called Fair Price Shops (FPS). These FPS in turn receive rice from government-run warehouses (called godowns) where rice is delivered from a central procurement system and then bagged.
- Conditions
- Anemia
- Being tested
- Fortified rice kernels
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified rice kernelsOther
The proposed project will leverage the existing state-run public distribution system (PDS) to provide fortified rice through Fair Price Shops (FPS) using a domestically manufactured rice grain (Fortified Rice Kernels: FRK). FRKs are grains made from rice flour, enriched with iron, zinc, Vitamin A, Vitamins B1, B3, B6, B9 and B12, and shaped like a conventional grain of rice. It is mixed into conventional rice in specified ratio of 1:100. The proposed study will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12-15 months apart. In the interim, 110 Treatment FPS, and all households receiving rice from them, will be randomly assigned to receive fortified rice, and another 110 randomly assigned Control FPS, and the households receiving rice from them, will continue receiving conventional rice and represents the status quo. This study will be conducted in one sub-district of Tamil Nadu with a population of about 1/2 million people.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 110 Fair Price Shops (FPS) in Chidambaram, Tamil Nadu, India will be assigned randomly to receive rice fortified. Rice will be fortified using Fortified Rice Kernels (FRKs) containing iron, zinc, vitamin A and vitamins B1, B3, B6, B9 and B12. All households receiving rice from the PDS will receive fortified rice instead of conventional PDS rice, and members of households sampled for baseline will have blood samples and demographic surveys taken at a baseline visit, and another visit at 12-15 months after the baseline visit. Because a given FPS only receives rice from a single upstream distributor (godown) it should be straightforward to ensure that fortified rice reaches the appropriate treatment FPS and only those FPS. Receives: Other: Fortified rice kernels |
| Control | No intervention | The control arm, i.e. FPS not a part of the treatment shops, will continue to receive the regular rice supplied by the Public Distribution System (PDS), and members of households sampled for baseline will have blood samples and demographic surveys taken at a baseline visit, and another visit at 12-15 months after the baseline visit. It therefore represents the status quo and serves as a control group against which any improvements observed in the treatment group will be gauged. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin level from baseline to endline using Rapid Diagnostic Tests (RDT)
Rapid Diagnostic Tests (RDT), using Hemocue machine, will be used to measure Hemoglobin concentrations in 40 women and 40 children tested in each FPS catchment area (total sample size 17600 women and children). Hemoglobin (Hb) will be tested with the HemoCue analyzer, a portable, accurate system for measuring Hb. Hb measures will be used to calculate prevalence of anemia among the target population of women and young children. The test requires less than 0.5 ml of blood and delivers results in approximately 15 minutes.
Measured: This will be assessed at baseline and at endline after 12-15 months of intervention.
Change in hemoglobin level from baseline to endline using DBS
Hemoglobin (Hb) will also be measured separately in a sub-sample of individuals (10 children and 10 women per FPS) using Dried Blood Spots (DBS) that will be transported to a lab for analysis. It will take up to 15 minutes for each respondent.
Measured: This will be assessed at baseline and at endline after 12-15 months of intervention.
Change in Transferrin Receptor (TfR) level from baseline to endline using DBS
Transferrin Receptor (TfR) will also be measured separately in a sub-sample of individuals (10 children and 10 women per FPS) using Dried Blood Spots (DBS) that will be transported to a lab for analysis. TfR is a good indicator of iron stores in the body, and this marker is expected to improve following food fortification. C-Reactive Protein (CRP) will also be measured. CRP is useful both to detect the presence of inflammation and to identify cases where measured TfR is likely to give a biased account of iron stores, given that TfR becomes elevated in the presence of acute and sometimes chronic infections; thus, TfR will be corrected for inflammation using CRP. It will take up to 15 minutes for each respondent.
Measured: This will be assessed at baseline and at endline after 12-15 months of intervention.
Change in anemia measured by RDT (Hemocue machine) and DBS from baseline to endline
Anemia measured by RDT (Hemocue machine) and DBS: Hb measured from RDT, i.e. Hemocue machine, and DBS will further be categorized to estimate the prevalence of anemia among the study population using established Hb thresholds. Based on the WHO classification, the following thresholds will be considered:
For children aged 6 to 59 months:
- No anemia: Hb >= 11 g/dL
- Mild anemia: 10 < Hb < 10.9 g/dL
- Moderate anemia: 7 < Hb < 9.9 g/dL
- Severe anemia: Hb < 7 g/dL
For non-pregnant women aged 12 years and above:
- No anemia: Hb >= 12 g/dL
- Mild anemia: 11 < Hb < 11.9 g/dL
- Moderate anemia: 8 < Hb < 10.9 g/dL
- Severe anemia: Hb < 8 g/dL
For pregnant women aged 12 years and above:
- No anemia: Hb >= 11 g/dL
- Mild anemia: 10 < Hb < 10.9 g/dL
- Moderate anemia: 7 < Hb < 9.9 g/dL
- Severe anemia: Hb < 7 g/dL
Measured: This will be assessed at baseline and at endline after 12-15 months of intervention.
Secondary outcomes (4)
Change in height from baseline to endline
Height will be measured for all study participants (children that are 6 months and older, and women between the ages of 12 and 40 years) at baseline and endline. This will take up to 10 minutes.
Measured: This will be assessed at baseline and at endline after 12-15 months of intervention.
Change in weight from baseline to endline
Weight will be measured for all study participants (children that are 6 months and older, and women between the ages of 12 and 40 years) at baseline and endline. This will take up to 10 minutes.
Measured: This will be assessed at baseline and at endline after 12-15 months of intervention.
Change in productivity from baseline to endline
Employment status, hours worked, productivity, and earnings will be measured for working age adults at baseline and endline. This will take approximately 10 minutes.
Measured: This will be assessed at baseline and at endline after 12-15 months of intervention.
Change in cognitive outcomes for children from baseline to endline
Cognitive outcomes for children using Development Milestones Checklist and Wechsler Preschool and Primary Scale of Intelligence instruments, as well as school enrollment and attendance data for older children will be measured. This will take approximately 30 minutes to administer.
Measured: This will be assessed at baseline and at endline after 12-15 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Apr 2018
- Primary completion31 Oct 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Why it stopped: The Government of Tamil Nadu decided not to proceed with implementation of fortified rice through the Public Distribution (per the original study protocol)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project (implementation and accompanying evaluation) will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12 months apart in the same individuals. In the interim, 110 Treatment Fair Price Shops (FPS) will be assigned randomly to receive rice fortified with iron and other micronutrients, and another 110 Control FPS will be assigned randomly to conventional Public Distribution System (PDS) rice. The control arm therefore represents the status quo and serves as a control group against which any improvements observed in the treatment group will be gauged.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Tamil Nadu, India, Global Innovation Fund, National AIDS Research Institute, King Philanthropies
- Responsible party
- Principal investigator, Grant Miller, Stanford University
- Investigators
- Norman G Miller, PhD, Principal investigator, Stanford UniversityAprajit Mahajan, PhD, Principal investigator, University of California, BerkeleyAlessandro Tarozzi, PhD, Principal investigator, Universitat Pompeu FabraReynaldo Martorell, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573570
- Sponsor's protocol ID
- IRB-35227
- Status last verified
- Mar 2021
- First submitted
- 25 May 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data will be shared upon successful publication of the main paper from the project.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Anemia Through Food Fortification at Scale
- ClinicalTrials.gov ID
- NCT03573570
- Acronym / sponsor ID
- IRB-35227
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Government of Tamil Nadu decided not to proceed with implementation of fortified rice through the Public Distribution (per the original study protocol)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Government of Tamil Nadu, India, Global Innovation Fund, National AIDS Research Institute, King Philanthropies
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 29 Jun 2018 (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.
Anemia is the most common form of malnutrition, affecting approximately 1.6 billion people world-wide. Most commonly caused by iron deficiency, its adverse effects include increased mortality (especially during childbirth), impaired cognitive development among children, chronic fatigue, and reduced lifetime earnings. While iron deficiency is the main cause of anemia worldwide, its etiology is complex and it can also be caused by an insufficient intake of other micronutrients such as Vitamin A, B9, B12 and folate as well as by helminthic infections and malaria.
Research in India and elsewhere has shown that under ideal (controlled) conditions, anemia can be reduced by consumption of iron-fortified food and other micro-nutrients. However, much less is known about the effectiveness of such interventions under actual program conditions on a large scale. This trial proposes to address anemia and other micronutrient deficiencies by providing micronutrient fortified rice through the Public Distribution System (PDS) of Tamil Nadu in a manner that requires no change in behaviour by end-user households and that can feasibly be conducted on a large scale.
This trial is designed as a rigorous cluster-randomized controlled trial with the full collaboration of the government of Tamil Nadu. The trial will follow a randomized cluster design at the Fair Price Shops (FPS) which distribute rice in the Tamil Nadu PDS. Fair Price Shops will be assigned randomly either to the treatment or the control arm, and will either be provided fortified rice for distribution, or the standard, non-fortified rice.
Detailed description
The proposed project will leverage the existing state-run public distribution system (PDS) to provide fortified rice using a domestically manufactured rice grain (Fortified Rice Kernels, or FRK). FRKs are grains made from rice flour, highly enriched with iron and other micronutrients (such as Vitamin A, B9 and Vitamin B12), and shaped like a conventional grain of rice. It is mixed into conventional rice in specified ratios (1g of FRK 100g of conventional rice) and is almost indistinguishable from conventional rice in appearance and taste. For this study, rice will be fortified using FRKs containing iron, zinc, vitamin A and vitamins B1, B3, B6, B9 and B12.
The Tamil Nadu PDS already provides up to 20 kilograms of rice at no cost to all households in the state, with an additional 15 kilograms to households identified as particularly poor. This is done through a widespread network of Fair Price Shops (FPS). The proposed study (implementation and accompanying evaluation) will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12-15 months apart. In the interim, 110 Treatment FPS will be randomly assigned to receive fortified rice, and another 110 randomly assigned Control FPS will continue receiving conventional rice. The investigators plan to conduct the study in one sub-district of Tamil Nadu with a population of about 1/2 million people.
In a cluster, the study team will randomly select 40 households to participate in the baseline and followup surveys and household members meeting the eligibility criteria, i.e. women between 12 and 40 years and children between 6 and 59 months, will be enrolled. These surveys will collect information about dietary patterns and socioeconomic status, and importantly, will also collect objectively measured health indicators (biomarkers and anthropometric measures), to test directly for anemia and micronutrient deficiencies.
To implement the intervention, the Government pre-existing PDS system, will be used. Every household in Tamil Nadu has a card that entitles it monthly to a pre-specified quantity of rice (and other goods) from a specific location that belongs to a network of so called Fair Price Shops (FPS). These FPS in turn receive rice from government-run warehouses (called godowns) where rice is delivered from a central procurement system and then bagged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This project (implementation and accompanying evaluation) will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12 months apart in the same individuals. In the interim, 110 Treatment Fair Price Shops (FPS) will be assigned randomly to receive rice fortified with iron and other micronutrients, and another 110 Control FPS will be assigned randomly to conventional Public Distribution System (PDS) rice. The control arm therefore represents the status quo and serves as a control group against which any improvements observed in the treatment group will be gauged.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Fortified rice kernels110 Fair Price Shops (FPS) in Chidambaram, Tamil Nadu, India will be assigned randomly to receive rice fortified. Rice will be fortified using Fortified Rice Kernels (FRKs) containing iron, zinc, vitamin A and vitamins B1, B3, B6, B9 and B12. All households receiving rice from the PDS will receive fortified rice instead of conventional PDS rice, and members of households sampled for baseline will have blood samples and demographic surveys taken at a baseline visit, and another visit at 12-15 months after the baseline visit. Because a given FPS only receives rice from a single upstream distributor (godown) it should be straightforward to ensure that fortified rice reaches the appropriate treatment FPS and only those FPS. |
| Control | No intervention | –The control arm, i.e. FPS not a part of the treatment shops, will continue to receive the regular rice supplied by the Public Distribution System (PDS), and members of households sampled for baseline will have blood samples and demographic surveys taken at a baseline visit, and another visit at 12-15 months after the baseline visit. It therefore represents the status quo and serves as a control group against which any improvements observed in the treatment group will be gauged. |
Who may qualify
- Ages
- 6 months to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children in the age group of 6 months to 5 years
- Women in the age group of 12 to 40 years
Key exclusion criteria (1 listed)
- None
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 rice kernelsThe proposed project will leverage the existing state-run public distribution system (PDS) to provide fortified rice through Fair Price Shops (FPS) using a domestically manufactured rice grain (Fortified Rice Kernels: FRK). FRKs are grains made from rice flour, enriched with iron, zinc, Vitamin A, Vitamins B1, B3, B6, B9 and B12, and shaped like a conventional grain of rice. It is mixed into conventional rice in specified ratio of 1:100. The proposed study will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12-15 months apart. In the interim, 110 Treatment FPS, and all households receiving rice from them, will be randomly assigned to receive fortified rice, and another 110 randomly assigned Control FPS, and the households receiving rice from them, will continue receiving conventional rice and represents the status quo. This study will be conducted in one sub-district of Tamil Nadu with a population of about 1/2 million people. | Other | Treatment |
Primary outcome
Change in hemoglobin level from baseline to endline using Rapid Diagnostic Tests (RDT)
Time frame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Rapid Diagnostic Tests (RDT), using Hemocue machine, will be used to measure Hemoglobin concentrations in 40 women and 40 children tested in each FPS catchment area (total sample size 17600 women and children). Hemoglobin (Hb) will be tested with the HemoCue analyzer, a portable, accurate system for measuring Hb. Hb measures will be used to calculate prevalence of anemia among the target population of women and young children. The test requires less than 0.5 ml of blood and delivers results in approximately 15 minutes.
Change in hemoglobin level from baseline to endline using DBS
Time frame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Hemoglobin (Hb) will also be measured separately in a sub-sample of individuals (10 children and 10 women per FPS) using Dried Blood Spots (DBS) that will be transported to a lab for analysis. It will take up to 15 minutes for each respondent.
Change in Transferrin Receptor (TfR) level from baseline to endline using DBS
Time frame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Transferrin Receptor (TfR) will also be measured separately in a sub-sample of individuals (10 children and 10 women per FPS) using Dried Blood Spots (DBS) that will be transported to a lab for analysis. TfR is a good indicator of iron stores in the body, and this marker is expected to improve following food fortification. C-Reactive Protein (CRP) will also be measured. CRP is useful both to detect the presence of inflammation and to identify cases where measured TfR is likely to give a biased account of iron stores, given that TfR becomes elevated in the presence of acute and sometimes chronic infections; thus, TfR will be corrected for inflammation using CRP. It will take up to 15 minutes for each respondent.
Change in anemia measured by RDT (Hemocue machine) and DBS from baseline to endline
Time frame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Anemia measured by RDT (Hemocue machine) and DBS: Hb measured from RDT, i.e. Hemocue machine, and DBS will further be categorized to estimate the prevalence of anemia among the study population using established Hb thresholds. Based on the WHO classification, the following thresholds will be considered: For children aged 6 to 59 months: * No anemia: Hb >= 11 g/dL * Mild anemia: 10 < Hb < 10.9 g/dL * Moderate anemia: 7 < Hb < 9.9 g/dL * Severe anemia: Hb < 7 g/dL For non-pregnant women aged 12 years and above: * No anemia: Hb >= 12 g/dL * Mild anemia: 11 < Hb < 11.9 g/dL * Moderate anemia: 8 < Hb < 10.9 g/dL * Severe anemia: Hb < 8 g/dL For pregnant women aged 12 years and above: * No anemia: Hb >= 11 g/dL * Mild anemia: 10 < Hb < 10.9 g/dL * Moderate anemia: 7 < Hb < 9.9 g/dL * Severe anemia: Hb < 7 g/dL
4 secondary outcomes
Change in height from baseline to endline
Time frame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Change in weight from baseline to endline
Time frame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Change in productivity from baseline to endline
Time frame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Change in cognitive outcomes for children from baseline to endline
Time frame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Yes. All de-identified data will be shared upon successful publication of the main paper from the project.
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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.
Norman G Miller, PhD principal investigator
Stanford University
Aprajit Mahajan, PhD principal investigator
University of California, Berkeley
Alessandro Tarozzi, PhD principal investigator
Universitat Pompeu Fabra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified rice kernels in people with Anemia, run by Stanford University at 1 site in India.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 18 Mar 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 India. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in hemoglobin level from baseline to endline using Rapid Diagnostic Tests (RDT) (time frame: This will be assessed at baseline and at endline after 12-15 months of intervention.). The study lists 4 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 18 Mar 2021.