Iron Deficiency AnemiaIDANCT01115023
Effect of Consuming Food Cooked in Iron Utensils on Iron Status in Children With Iron Deficiency Anemia (IDA)
A study testing iron cooking pot in people with Iron Deficiency Anemia, run by Dhande, Leena Ajay, M.D. at 1 site in India.
Trial summary
Iron deficiency is a common problem in the world and more so in the developing countries with a prevalence of 64 % (using WHO cut-off values of Hb <11.0 g/dl) among children, 9-36 months of age. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- iron cooking pot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2003to Nov 2004
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2-12 years,
- Resident of urban Nagpur
- Diagnosed as having non-severe IDA defined as Hb% > 5gm% but less than cut off point for age for diagnosing anemia.
Who cannot join
- Suffering from Hemoglobinopathy or Iron overload due to any cause
- Receiving Iron therapy
- Malabsorption
- Bleeding diathesis
- Chronic illness
- Participation in another trial in last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Study the Effect of Consuming Food Cooked in Iron Utensils on Iron Status in Children With Iron Deficiency Anemia (IDA)
Iron deficiency is a common problem in the world and more so in the developing countries with a prevalence of 64 % (using WHO cut-off values of Hb <11.0 g/dl) among children, 9-36 months of age. The Pediatric population is especially vulnerable to iron deficiency anemia due to low intake of iron rich foods, rapid growth with high demand and losses of iron from body especially with the commonly found worm infestations in children. Mild to moderate iron deficiency is widely prevalent in children and can have several implications including failure to thrive, poor scholastic performance, repeated infections etc. Dietary measures along with therapeutic measures are recommended to combat Iron Deficiency Anemia (IDA). However, iron rich foods alone cannot be relied upon as a sole step to counter IDA. The utensil in which the food is cooked plays a major role in determining the final iron content of food. Several studies have documented that most of the foods (90%) contained significantly more iron when cooked in iron utensils depending on the acidity, moisture content, and cooking time of food.The daily dietary intake could vary from 11 to 6 mg of iron if iron utensil was used for cooking [3].
Food cooked in Aluminum (Al) utensils has a higher Al content which can be detrimental to healthy individuals and particularly to patients with chronic renal failure.In healthy persons, diseases of central nervous system, as well as of hematopoeitic system, skeletal system and respiratory system are described due to excess of Aluminium consumption. Aluminium utensils have fast replaced iron cooking pots from Indian kitchens, hence a study to know the effectiveness of iron cooking pot as a measure to combat IDA is necessary.
Read more
Studies have shown the utility of cooking food in iron utensil in prevention of IDA but the investigators did not come across a study to document the use of this modality in treatment of IDA in children. Since the investigators anticipate that the improvement of iron status will be a gradual process, so the investigators decided to evaluate the utility of cooking food in iron utensils on iron status in children with non-severe IDA (Hb% < cutoff point for age but > 5 gm %.
To test the following hypothesis "use of iron utensils for cooking food will result in improvement in iron status in Pediatric patients with nonsevere Iron Deficiency Anemia."
Read the detailed description
Dietary advice and iron therapy are considered the cornerstones of treating a patient with non-severe IDA. The foods that are rich in Iron include meat and poultry products, egg, green leafy vegetables, jaggery, dry fruits etc. Iron in food is of two types viz. haem iron and non haem iron. Haem Iron has excellent bioavailability but the bioavailability of the non-haem Iron in the food stuffs is considerably affected by the presence of substances like phosphates, phytates, tannins and fibres. On the other hand, Ascorbic acid, sugars and other acidic substances in the food enhance the iron absorption. The bulk of food consumed by a child is too less to provide him with therapeutic amounts of iron form diet alone. In the developing countries, the child is quite unlikely to get poultry products and meat as a source of haem Iron. If in this situation, the child is provided with food cooked in Iron utensil, then it provides additional Iron to meet the increased demand. This will not only be cost effective but it will also alter the cooking practices and thereby have a long term effect on the iron status of the entire family. Thus it will treat the IDA in the index case and will also benefit other family members who may be having borderline or overt iron deficiency. This cost effective measure if incorporated in the health policy of the country will certainly have widespread positive implications on the health of the general population.
- Conditions
- Iron Deficiency Anemia
- Being tested
- iron cooking pot
- Keywords
- iron deficiency anemia, dietary intervention, To evaluate a cheap and sustainable dietary intervention to improve the iron status of the entire family of the index case of non-severe iron deficiency anemia.
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron cooking potOther
the mother was instructed to cook the family food in the iron cooking pot for the study period (60 days) as frequently in the day as possible.
| Study group | Role | What they receive |
|---|---|---|
| iron group | Experimental | This group received an iron cooking pot for daily household cooking as an intervention Receives: Other: iron cooking pot |
| Aluminium group | No intervention | the subjects in this group were asked to continue cooking in the aluminium pot and not to cook in the iron pot if they possessed one. |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the rise in Hemoglobin at the end of 60 days period in the iron group vs the aluminium group.
Measured: 60 days
Secondary outcomes (1)
to compare the change in RDW, RBC indices and Reticulocyte count at the end of 60 days period in the iron group vs the aluminium group.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startOct 2003
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhande, Leena Ajay, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Gangadharrao Chitnavis Memorial Medical Research Trust Nagpur
- Investigators
- Leena Ajay Dhande, MD (Pediatrics), Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115023
- Sponsor's protocol ID
- L1IDA1
- Acronym
- IDA
- Status last verified
- Apr 2010
- First submitted
- 30 Apr 2010
- Last updated
- 3 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Study the Effect of Consuming Food Cooked in Iron Utensils on Iron Status in Children With Iron Deficiency Anemia (IDA)
- ClinicalTrials.gov ID
- NCT01115023
- Acronym / sponsor ID
- IDA / L1IDA1
- Conditions
- Iron Deficiency Anemia
- Keywords
- iron deficiency anemia, dietary intervention, To evaluate a cheap and sustainable dietary intervention to improve the iron status of the entire family of the index case of non-severe iron deficiency anemia.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dhande, Leena Ajay, M.D.University, hospital or other
- Collaborators
- Sir Gangadharrao Chitnavis Memorial Medical Research Trust Nagpur
- Study start
- Oct 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 3 May 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 a common problem in the world and more so in the developing countries with a prevalence of 64 % (using WHO cut-off values of Hb <11.0 g/dl) among children, 9-36 months of age. The Pediatric population is especially vulnerable to iron deficiency anemia due to low intake of iron rich foods, rapid growth with high demand and losses of iron from body especially with the commonly found worm infestations in children. Mild to moderate iron deficiency is widely prevalent in children and can have several implications including failure to thrive, poor scholastic performance, repeated infections etc. Dietary measures along with therapeutic measures are recommended to combat Iron Deficiency Anemia (IDA). However, iron rich foods alone cannot be relied upon as a sole step to counter IDA. The utensil in which the food is cooked plays a major role in determining the final iron content of food. Several studies have documented that most of the foods (90%) contained significantly more iron when cooked in iron utensils depending on the acidity, moisture content, and cooking time of food.The daily dietary intake could vary from 11 to 6 mg of iron if iron utensil was used for cooking [3].
Food cooked in Aluminum (Al) utensils has a higher Al content which can be detrimental to healthy individuals and particularly to patients with chronic renal failure.In healthy persons, diseases of central nervous system, as well as of hematopoeitic system, skeletal system and respiratory system are described due to excess of Aluminium consumption. Aluminium utensils have fast replaced iron cooking pots from Indian kitchens, hence a study to know the effectiveness of iron cooking pot as a measure to combat IDA is necessary.
Studies have shown the utility of cooking food in iron utensil in prevention of IDA but the investigators did not come across a study to document the use of this modality in treatment of IDA in children. Since the investigators anticipate that the improvement of iron status will be a gradual process, so the investigators decided to evaluate the utility of cooking food in iron utensils on iron status in children with non-severe IDA (Hb% < cutoff point for age but > 5 gm %.
To test the following hypothesis "use of iron utensils for cooking food will result in improvement in iron status in Pediatric patients with nonsevere Iron Deficiency Anemia."
Detailed description
Dietary advice and iron therapy are considered the cornerstones of treating a patient with non-severe IDA. The foods that are rich in Iron include meat and poultry products, egg, green leafy vegetables, jaggery, dry fruits etc. Iron in food is of two types viz. haem iron and non haem iron. Haem Iron has excellent bioavailability but the bioavailability of the non-haem Iron in the food stuffs is considerably affected by the presence of substances like phosphates, phytates, tannins and fibres. On the other hand, Ascorbic acid, sugars and other acidic substances in the food enhance the iron absorption. The bulk of food consumed by a child is too less to provide him with therapeutic amounts of iron form diet alone. In the developing countries, the child is quite unlikely to get poultry products and meat as a source of haem Iron. If in this situation, the child is provided with food cooked in Iron utensil, then it provides additional Iron to meet the increased demand. This will not only be cost effective but it will also alter the cooking practices and thereby have a long term effect on the iron status of the entire family. Thus it will treat the IDA in the index case and will also benefit other family members who may be having borderline or overt iron deficiency. This cost effective measure if incorporated in the health policy of the country will certainly have widespread positive implications on the health of the general population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iron group | Experimental | Other: iron cooking potThis group received an iron cooking pot for daily household cooking as an intervention |
| Aluminium group | No intervention | –the subjects in this group were asked to continue cooking in the aluminium pot and not to cook in the iron pot if they possessed one. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 2-12 years,
- Resident of urban Nagpur
- Diagnosed as having non-severe IDA defined as Hb% > 5gm% but less than cut off point for age for diagnosing anemia.
Key exclusion criteria (6 listed)
- Suffering from Hemoglobinopathy or Iron overload due to any cause
- Receiving Iron therapy
- Malabsorption
- Bleeding diathesis
- Chronic illness
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 cooking potthe mother was instructed to cook the family food in the iron cooking pot for the study period (60 days) as frequently in the day as possible. | Other | iron group |
Primary outcome
to compare the rise in Hemoglobin at the end of 60 days period in the iron group vs the aluminium group.
Time frame: 60 days
1 secondary outcome
to compare the change in RDW, RBC indices and Reticulocyte count at the end of 60 days period in the iron group vs the aluminium group.
Time frame: 60 days
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 3 May 2010.
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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.
Leena Ajay Dhande, MD (Pediatrics) principal investigator
Associate Professor
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 cooking pot in people with Iron Deficiency Anemia, run by Dhande, Leena Ajay, M.D. 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 3 inclusion and 6 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 3 May 2010. 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?
to compare the rise in Hemoglobin at the end of 60 days period in the iron group vs the aluminium group. (time frame: 60 days). 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 3 May 2010.