Iron-deficiencyNCT04623918
Iron-Biofortified Rice Intervention in the Philippines
A study testing Iron-biofortified rice in people with Iron-deficiency and Anemia, run by Cornell University at 1 site in Philippines.
Trial summary
The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. 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, Anemia
- What is being tested?
- Iron-biofortified rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Jun 2002to 31 Dec 2003
- 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
- Women (18-45 years old) living in convents in the greater Manila area
- Hb ≥10.5 g/dL
Who cannot join
- Current or history of gastrointestinal or hematological disorders
- Taking iron supplements or medications that could interfere with hematopoiesis or dietary iron absorption
- Hb <10.5 g/dL
- Women expressed uncertainty in their ability to participate for the full (9 month) trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Iron-Biofortified Rice in Women in the Philippines
The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. A randomized trial of biofortified rice (IR68144-2B-2-2-3), bred to enhance iron content, was conducted among women living in convents in the greater area of Manila, Philippines for 9 months.
Read the detailed description
Iron deficiency is the most prevalent nutritional deficiency globally, with the highest burden in women of reproductive age and children. In this randomized controlled trial, 317 women aged 18-45 years living in convents in the greater Manila area, Philippines, were fed meals using either biofortified or commercially available rice for all meals, 7 days a week, for 9 months. Women living in convents in the greater Manila area were recruited for this study. These women represent a segment of the population at high risk for iron deficiency, consume large quantities of rice, and all of their meals are prepared and consumed in common kitchen and dining areas, respectively.
The investigators hypothesized that daily consumption of iron-biofortified rice (IR68144-2B-2-2-3) would improve hemoglobin, serum ferritin, and total body iron in 9 months, compared to control rice. In order to examine this hypothesis, the investigators conducted a randomized efficacy trial of iron-biofortified rice and iron status in among women living in convents in the greater area of Manila, Philippines for 9 months.
The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice.
The long-term goal of this study is to determine if iron bio-fortification of rice is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.
- Conditions
- Iron-deficiency, Anemia
- Being tested
- Iron-biofortified rice, Control rice
- Keywords
- Anemia, Iron, Biofortification, Philippines, Iron deficiency, Women of reproductive age
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-biofortified riceOther
Iron-biofortified rice (IR68144-2B-2-2-3)
Control riceOther
Control rice (C4), identical in appearance
| Study group | Role | What they receive |
|---|---|---|
| Iron-biofortified rice | Experimental | Iron-biofortified rice (IR68144-2B-2-2-3) Receives: Other: Iron-biofortified rice |
| Control rice | Active comparator | Control rice (C4) Receives: Other: Control rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ferritin
Serum ferritin (SF)
Measured: 9 months
Change in sTfR
Soluble transferrin receptor (sTfR)
Measured: 9 months
Change in TBI
Total body iron (TBI)
Measured: 9 months
Secondary outcomes (4)
Change in hemoglobin among women who were anemic at baseline
Changes in hemoglobin (Hb) in women who were anemic at baseline
Measured: 9 months
Changes in SF among women who were non-anemic at baseline
Changes in SF among women who were non-anemic at baseline
Measured: 9 months
Changes in sTfR among women who were non-anemic at baseline
Changes in sTfR among women who were non-anemic at baseline
Measured: 9 months
Changes in TBI among women who were non-anemic at baseline
Changes in TBI among women who were non-anemic at baseline
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Jun 2002
- Primary completion31 Dec 2003
- Study completion31 Dec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, University of the Philippines
- Responsible party
- Sponsor
- Investigators
- Jere Haas, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623918
- Sponsor's protocol ID
- Haas2005
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haas JD, Beard JL, Murray-Kolb LE, del Mundo AM, Felix A, Gregorio GB. Iron-biofortified rice improves the iron stores of nonanemic Filipino women. J Nutr. 2005 Dec;135(12):2823-30. doi: 10.1093/jn/135.12.2823.
PubMed 16317127
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Iron-Biofortified Rice in Women in the Philippines
- ClinicalTrials.gov ID
- NCT04623918
- Acronym / sponsor ID
- Haas2005
- Conditions
- Iron-deficiency, Anemia
- Keywords
- Anemia, Iron, Biofortification, Philippines, Iron deficiency, Women of reproductive age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Penn State University, University of the Philippines
- Study start
- 1 Jun 2002 (actual)
- Primary completion
- 31 Dec 2003 (actual)
- Study completion
- 31 Dec 2003 (actual)
- First posted
- 10 Nov 2020 (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 objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. A randomized trial of biofortified rice (IR68144-2B-2-2-3), bred to enhance iron content, was conducted among women living in convents in the greater area of Manila, Philippines for 9 months.
Detailed description
Iron deficiency is the most prevalent nutritional deficiency globally, with the highest burden in women of reproductive age and children. In this randomized controlled trial, 317 women aged 18-45 years living in convents in the greater Manila area, Philippines, were fed meals using either biofortified or commercially available rice for all meals, 7 days a week, for 9 months. Women living in convents in the greater Manila area were recruited for this study. These women represent a segment of the population at high risk for iron deficiency, consume large quantities of rice, and all of their meals are prepared and consumed in common kitchen and dining areas, respectively.
The investigators hypothesized that daily consumption of iron-biofortified rice (IR68144-2B-2-2-3) would improve hemoglobin, serum ferritin, and total body iron in 9 months, compared to control rice. In order to examine this hypothesis, the investigators conducted a randomized efficacy trial of iron-biofortified rice and iron status in among women living in convents in the greater area of Manila, Philippines for 9 months.
The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice.
The long-term goal of this study is to determine if iron bio-fortification of rice is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron-biofortified rice | Experimental | Other: Iron-biofortified riceIron-biofortified rice (IR68144-2B-2-2-3) |
| Control rice | Active comparator | Other: Control riceControl rice (C4) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women (18-45 years old) living in convents in the greater Manila area
- Hb ≥10.5 g/dL
Key exclusion criteria (4 listed)
- Current or history of gastrointestinal or hematological disorders
- Taking iron supplements or medications that could interfere with hematopoiesis or dietary iron absorption
- Hb <10.5 g/dL
- Women expressed uncertainty in their ability to participate for the full (9 month) trial
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 |
|---|---|---|
| Iron-biofortified riceIron-biofortified rice (IR68144-2B-2-2-3) | Other | Iron-biofortified rice |
| Control riceControl rice (C4), identical in appearance | Other | Control rice |
Primary outcome
Change in serum ferritin
Time frame: 9 months
Serum ferritin (SF)
Change in sTfR
Time frame: 9 months
Soluble transferrin receptor (sTfR)
Change in TBI
Time frame: 9 months
Total body iron (TBI)
4 secondary outcomes
Change in hemoglobin among women who were anemic at baseline
Time frame: 9 months
Changes in SF among women who were non-anemic at baseline
Time frame: 9 months
Changes in sTfR among women who were non-anemic at baseline
Time frame: 9 months
Changes in TBI among women who were non-anemic at baseline
Time frame: 9 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 13 Nov 2020.
- Background: PubMed 16317127Haas JD, Beard JL, Murray-Kolb LE, del Mundo AM, Felix A, Gregorio GB. Iron-biofortified rice improves the iron stores of nonanemic Filipino women. J Nutr. 2005 Dec;135(12):2823-30. doi: 10.1093/jn/135.12.2823.
- 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.
Jere Haas principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron-biofortified rice in people with Iron-deficiency and Anemia, run by Cornell University at 1 site in Philippines.
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 4 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 13 Nov 2020. 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 Philippines. 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?
Change in serum ferritin (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623918, which also lists 1 linked publication.
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 13 Nov 2020.