Iron DeficiencyMUGUST_2NCT01191463
The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals and Its Effect on Iron Status of Rural Indian Children (6-10 Years)
A study testing Mung Bean Meal and Guava in people with Iron Deficiency and Anemia, run by Wageningen University at 1 site in India.
Trial summary
Iron deficiency is estimated to affect about one fifth of the world's population, and women and children are among the most severely affected. Evidence is mounting that iron deficiency anemia adversely affects brain development with measurable effects on children's behavior, motor development and cognition. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anemia
- What is being tested?
- Mung Bean Meal and Guava
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2010to Apr 2011
- 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 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- School children (6-10) years of age
- Enrolled in selected primary schools
- Informed consent obtained from at least one parent or guardian
- Children should be apparently healthy; i.e. have no pre-existing medical conditions or be receiving chronic medication.
- Should not be allergic / hypersensitive to any of the ingredients of the test meal
- Should not consume mineral/vitamin supplements. If the child consume supplements he/she will be asked to stop taking the supplements two weeks before the study and during the study
Who cannot join
- Subjects with severe anemia (Hb=70 g/L)will be referred for treatement at the local health facility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals in Indian Children (6-10 Years)
Iron deficiency is estimated to affect about one fifth of the world's population, and women and children are among the most severely affected. Evidence is mounting that iron deficiency anemia adversely affects brain development with measurable effects on children's behavior, motor development and cognition. In Hisar district of Haryana state, north- India, 58% of school age children (6-10 years) are anemic, 49 % are iron deficient whereas 40 % have been found to be anemic due to iron deficiency. Iron bioavailability calculated using algorithms in regional diets ranged from 3.2 to 4.6 percent. Mungbean (Vigna radiata L.) is the third most important legume crop of India. It is a high potential legume crop with 4-8 mg of iron and known as a nutritious and healthy legume. Ascorbic acid is a potent enhancer of iron absorption in humans which can counteract the inhibitory effect of phytic acid and polyphenols. Guava is a popular and easily available fruit for this community having 200- 300 mg/100g of ascorbic acid. We will conduct a randomised controlled trial in school age children (6-10 years) in Haryana state of India, to determine the efficacy of local vitamin-C rich fruit guava with mungbean based meal on iron status of rural Indian children.
Objective: To assess the effect of mungbean based test meal on iron status (as body iron stores, defined and calculated by the ratio of serum ferritin and serum transferrin receptor) of school age children (6-10 years) with and without the consumption of guava, a vitamin C rich fruit, in a school feeding program for seven months.
Read more
Study population: Three hundred school children aged between 6-10 years will be recruited from two government school of Mangali village situated in Hisar district of Haryana state.
Study design: This intervention study will be carried out in a randomized controlled design. Main study parameters/endpoints: Primary outcome will be the measurement of body iron stores (mg/kg of body weight) based on the ratio of serum transferrin receptor to serum ferritin.
Read the detailed description
Primary Objective To measure the effect of mungbean based test meal on iron status (defined by body iron stores, calculated as the ratio of ferritin and serum transferrin receptor) of school age children (6-10 years) with and without the consumption of guava, a vitamin C rich fruit, distributing in school feeding program for seven months.
Three weeks before the trial available children (6-10 years) in selected schools will be screened for eligibility of the study on the basis of medical health questionnaire. Deworming will be done at least 20 days before the start the feeding trial with a single dose of Albendazole (400 mg), that will be given again after three months. These 300 children will be assigned to three groups (100 children each group). Group-1 will be served with the normal school feeding program (SFP) meal (see annexure-1) and this group will also serve as control group for the study. Group-2 will be served with mungbean test meal (see annexure-2) and group-3 will be served with guava fruit in addition of mungbean test meal. Meals to all children will be provided for six days in a week up to seven months. All meals will be served at mid morning (11.00 am to 11.30 am). Effect of intervention will be assessed in terms of iron status of children.
This study will be carried out in two government schools of Mangali village belong to Hisar-1 block of Hisar district Haryana state with the close supervision of Chaudhary Charan Singh Haryana Agriculture University, Hisar.
Children having severe anemia (Hb <7.0 g/dl) will be excluded from the trial and referred for medical treatment.
Subjects will be recruited that comply with the following criteria:
- School children (6-10) years of age,
- enrolled in selected primary schools,
- Informed consent obtained from at least one parent or guardian,
- Children should be apparently healthy; i.e. have no pre-existing medical conditions or be receiving chronic medication,
- Should not be allergic / hypersensitive to any of the ingredients of the test meal, Should not consume mineral/vitamin supplements.
- If the child consume supplements he/she will be asked to stop taking the supplements two weeks before the study and during the study.
A total of two blood samples will be taken from the participants, one at the start of the study, and second at the end of the study. With each sampling 7ml blood will be taken by an experienced technician. Blood will always be drawn in the morning between 7.30 and 9.00am at particular school by the well trained technician. Hemoglobin in whole blood, serum ferritin (Sf), serum transferrin receptor (sTfR), serum CRP and AGP will be analysed to compare the iron status. Body iron stores will be calculated with the formula by Cook et. al. All analysis will be carried out at the same time for both samples of baseline and after intervention at St. John hospital, Bangalore. Therefore serum samples of baseline will be stored for seven months at - 800c temperature. The CV of intra-assays and inter-assays will be, monitored. Blood samples will not be destroyed after completion the study they will be kept for up to 5 years.
Iron status will be compared in children belonging to three different groups in pre and post conditions, using above mentioned iron status indicators. Height and weight of the children will also be measured at pre and post of the intervention study. The primary outcome of this study will be body iron stores calculated with the cook formula.
Secondary outcomes will be prevalence of iron deficiency, anaemia, and difference in haemoglobin concentration and plasma concentrations of ferritin, and soluble transferring receptor in the two treatment groups. Anemia will be defined as a hemoglobin concentration <11.5g/L and iron deficiency will be defined as an SF concentration <12µg/l. The cut-off for normal CRP and AGP are defined at <5mg/L and <1g/L(12), respectively. Anthropometric indices will be calculated using WHO (2006) (10) Child growth standards. Being stunted, underweight or wasted will be defined by Z score <-2SD for height-for-age, weight-for-age and weight-for-height respectively.
- Conditions
- Iron Deficiency, Anemia
- Being tested
- Mung Bean Meal, Guava
- Medical subject headings
- Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mung Bean MealOther
50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables.
GuavaOther
A fresh Guava fruit will be provided raw (approx 100g fresh weight)
| Study group | Role | What they receive |
|---|---|---|
| Mung Bean Meals and Guava fruit | Experimental | Subject in this group will receive, a lunch meal based on 50g of Mung beans together with a local, Vitamin C rich fruit (Guava) Receives: Other: Mung Bean Meal; Other: Guava |
| Mung Bean | Active comparator | Subjects in this group will receive a lunch meal based on 50g mung beans but without any vitamin C source. Receives: Other: Mung Bean Meal |
| School feeding program | No intervention | Subjects in this arm, will receive the regular school feeding program as provided by the school authorities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Iron Stores
Defined as the ration between serum ferritin and soluble serum transferrin recpetor Body iron stores are a sensitive measure of body iron balance and indicative of body iron changes.
Measured: Baseline (Start month=0), End of study (Month=7)
Secondary outcomes (1)
Prevalence of iron deficiency, Prevalence of Iron deficiency anemia
Anemia will be defined as a hemoglobin concentration <11.5g/L and iron deficiency will be defined as an SF concentration <12µg/l.
Measured: Begin (Month=0), End (Month=7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- CCS Haryana Agricultural University Hisar, India
- Responsible party
- Sponsor
- Investigators
- Varsha Rani, PhD, Principal investigator, Wageningen University, Haryana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191463
- Sponsor's protocol ID
- MUGUST_2
- Acronym
- MUGUST_2
- Status last verified
- Sep 2010
- First submitted
- 27 Aug 2010
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rani, V., Brouwer, Inge., Khetarpaul, N., Zimmerman, M.B. (2009) Iron status and associated factors in rural school going children (5-8 years) of Haryana state, India., Abstract Book Wageningen Nutritional Sciences Forum March 4-6, 2009 European Journal of Clinical Nutrition, 63 (3S) Pp:20
Rani V, Moretti D, Khetarpaul N, Thankachan P, Zimmermann MB, Melse-Boonstra A, Brouwer ID. Vitamin C-Rich Guava Consumed with Mungbean Dal Reduces Anemia and Increases Hemoglobin but not Iron Stores: A Randomized Controlled Trial of Food-to-Food Fortification in Indian Children. J Nutr. 2024 Dec;154(12):3740-3748. doi: 10.1016/j.tjnut.2024.10.042. Epub 2024 Oct 30.
PubMed 39481541
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals in Indian Children (6-10 Years)
- ClinicalTrials.gov ID
- NCT01191463
- Acronym / sponsor ID
- MUGUST_2 / MUGUST_2
- Conditions
- Iron Deficiency, Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- CCS Haryana Agricultural University Hisar, India
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 Aug 2010 (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.
Iron deficiency is estimated to affect about one fifth of the world's population, and women and children are among the most severely affected. Evidence is mounting that iron deficiency anemia adversely affects brain development with measurable effects on children's behavior, motor development and cognition. In Hisar district of Haryana state, north- India, 58% of school age children (6-10 years) are anemic, 49 % are iron deficient whereas 40 % have been found to be anemic due to iron deficiency. Iron bioavailability calculated using algorithms in regional diets ranged from 3.2 to 4.6 percent. Mungbean (Vigna radiata L.) is the third most important legume crop of India. It is a high potential legume crop with 4-8 mg of iron and known as a nutritious and healthy legume. Ascorbic acid is a potent enhancer of iron absorption in humans which can counteract the inhibitory effect of phytic acid and polyphenols. Guava is a popular and easily available fruit for this community having 200- 300 mg/100g of ascorbic acid. We will conduct a randomised controlled trial in school age children (6-10 years) in Haryana state of India, to determine the efficacy of local vitamin-C rich fruit guava with mungbean based meal on iron status of rural Indian children.
Objective: To assess the effect of mungbean based test meal on iron status (as body iron stores, defined and calculated by the ratio of serum ferritin and serum transferrin receptor) of school age children (6-10 years) with and without the consumption of guava, a vitamin C rich fruit, in a school feeding program for seven months.
Study population: Three hundred school children aged between 6-10 years will be recruited from two government school of Mangali village situated in Hisar district of Haryana state.
Study design: This intervention study will be carried out in a randomized controlled design. Main study parameters/endpoints: Primary outcome will be the measurement of body iron stores (mg/kg of body weight) based on the ratio of serum transferrin receptor to serum ferritin.
Detailed description
Primary Objective To measure the effect of mungbean based test meal on iron status (defined by body iron stores, calculated as the ratio of ferritin and serum transferrin receptor) of school age children (6-10 years) with and without the consumption of guava, a vitamin C rich fruit, distributing in school feeding program for seven months.
Three weeks before the trial available children (6-10 years) in selected schools will be screened for eligibility of the study on the basis of medical health questionnaire. Deworming will be done at least 20 days before the start the feeding trial with a single dose of Albendazole (400 mg), that will be given again after three months. These 300 children will be assigned to three groups (100 children each group). Group-1 will be served with the normal school feeding program (SFP) meal (see annexure-1) and this group will also serve as control group for the study. Group-2 will be served with mungbean test meal (see annexure-2) and group-3 will be served with guava fruit in addition of mungbean test meal. Meals to all children will be provided for six days in a week up to seven months. All meals will be served at mid morning (11.00 am to 11.30 am). Effect of intervention will be assessed in terms of iron status of children.
This study will be carried out in two government schools of Mangali village belong to Hisar-1 block of Hisar district Haryana state with the close supervision of Chaudhary Charan Singh Haryana Agriculture University, Hisar.
Children having severe anemia (Hb <7.0 g/dl) will be excluded from the trial and referred for medical treatment.
Subjects will be recruited that comply with the following criteria:
- School children (6-10) years of age,
- enrolled in selected primary schools,
- Informed consent obtained from at least one parent or guardian,
- Children should be apparently healthy; i.e. have no pre-existing medical conditions or be receiving chronic medication,
- Should not be allergic / hypersensitive to any of the ingredients of the test meal, Should not consume mineral/vitamin supplements.
- If the child consume supplements he/she will be asked to stop taking the supplements two weeks before the study and during the study.
A total of two blood samples will be taken from the participants, one at the start of the study, and second at the end of the study. With each sampling 7ml blood will be taken by an experienced technician. Blood will always be drawn in the morning between 7.30 and 9.00am at particular school by the well trained technician. Hemoglobin in whole blood, serum ferritin (Sf), serum transferrin receptor (sTfR), serum CRP and AGP will be analysed to compare the iron status. Body iron stores will be calculated with the formula by Cook et. al. All analysis will be carried out at the same time for both samples of baseline and after intervention at St. John hospital, Bangalore. Therefore serum samples of baseline will be stored for seven months at - 800c temperature. The CV of intra-assays and inter-assays will be, monitored. Blood samples will not be destroyed after completion the study they will be kept for up to 5 years.
Iron status will be compared in children belonging to three different groups in pre and post conditions, using above mentioned iron status indicators. Height and weight of the children will also be measured at pre and post of the intervention study. The primary outcome of this study will be body iron stores calculated with the cook formula.
Secondary outcomes will be prevalence of iron deficiency, anaemia, and difference in haemoglobin concentration and plasma concentrations of ferritin, and soluble transferring receptor in the two treatment groups. Anemia will be defined as a hemoglobin concentration <11.5g/L and iron deficiency will be defined as an SF concentration <12µg/l. The cut-off for normal CRP and AGP are defined at <5mg/L and <1g/L(12), respectively. Anthropometric indices will be calculated using WHO (2006) (10) Child growth standards. Being stunted, underweight or wasted will be defined by Z score <-2SD for height-for-age, weight-for-age and weight-for-height respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mung Bean Meals and Guava fruit | Experimental | Other: Mung Bean Meal, Other: GuavaSubject in this group will receive, a lunch meal based on 50g of Mung beans together with a local, Vitamin C rich fruit (Guava) |
| Mung Bean | Active comparator | Other: Mung Bean MealSubjects in this group will receive a lunch meal based on 50g mung beans but without any vitamin C source. |
| School feeding program | No intervention | –Subjects in this arm, will receive the regular school feeding program as provided by the school authorities |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- School children (6-10) years of age
- Enrolled in selected primary schools
- Informed consent obtained from at least one parent or guardian
- Children should be apparently healthy; i.e. have no pre-existing medical conditions or be receiving chronic medication.
- Should not be allergic / hypersensitive to any of the ingredients of the test meal
Key exclusion criteria (1 listed)
- Subjects with severe anemia (Hb=70 g/L)will be referred for treatement at the local health facility.
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 |
|---|---|---|
| Mung Bean Meal50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables. | Other | Mung Bean, Mung Bean Meals and Guava fruit |
| GuavaA fresh Guava fruit will be provided raw (approx 100g fresh weight) | Other | Mung Bean Meals and Guava fruit |
Primary outcome
Body Iron Stores
Time frame: Baseline (Start month=0), End of study (Month=7)
Defined as the ration between serum ferritin and soluble serum transferrin recpetor Body iron stores are a sensitive measure of body iron balance and indicative of body iron changes.
1 secondary outcome
Prevalence of iron deficiency, Prevalence of Iron deficiency anemia
Time frame: Begin (Month=0), End (Month=7)
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 29 Sep 2011.
- BackgroundRani, V., Brouwer, Inge., Khetarpaul, N., Zimmerman, M.B. (2009) Iron status and associated factors in rural school going children (5-8 years) of Haryana state, India., Abstract Book Wageningen Nutritional Sciences Forum March 4-6, 2009 European Journal of Clinical Nutrition, 63 (3S) Pp:20
- Derived from this study: PubMed 39481541Rani V, Moretti D, Khetarpaul N, Thankachan P, Zimmermann MB, Melse-Boonstra A, Brouwer ID. Vitamin C-Rich Guava Consumed with Mungbean Dal Reduces Anemia and Increases Hemoglobin but not Iron Stores: A Randomized Controlled Trial of Food-to-Food Fortification in Indian Children. J Nutr. 2024 Dec;154(12):3740-3748. doi: 10.1016/j.tjnut.2024.10.042. Epub 2024 Oct 30.
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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.
Varsha Rani, PhD principal investigator
Wageningen University, Haryana 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 Mung Bean Meal and Guava in people with Iron Deficiency and Anemia, run by Wageningen 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 6 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: finished, as of the sponsor's last update on 29 Sep 2011. 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 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?
Body Iron Stores (time frame: Baseline (Start month=0), End of study (Month=7)). 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 NCT01191463, which also lists 2 linked publications.
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 29 Sep 2011.