- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01115023
Effect of Consuming Food Cooked in Iron Utensils on Iron Status in Children With Iron Deficiency Anemia (IDA) (IDA)
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.
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."
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maharashtra
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Nagpur, Maharashtra, India, 440003
- Government Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Inclusion criteria
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: iron group
This group received an iron cooking pot for daily household cooking as an intervention
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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.
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NO_INTERVENTION: Aluminium group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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60 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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60 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leena Ajay Dhande, MD (Pediatrics), Associate Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- L1IDA1
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Clinical Trials on Iron Deficiency Anemia
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Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
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King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
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Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute... and other collaboratorsCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)Peru
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Luzerner KantonsspitalRecruitingIron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron DeficienciesSwitzerland
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Children's Hospital Los AngelesWithdrawnAnemia | Iron-deficiency Anemia | Healthy ControlsUnited States
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Baylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
-
Iowa State UniversityCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron Deficiency Anaemia Due to Dietary CausesUnited States
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Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
Clinical Trials on iron cooking pot
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Weill Medical College of Cornell UniversityTerminated
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Children's Hospital of PhiladelphiaLucky Iron FishCompletedIron-deficiency | Iron Deficiency AnemiaDominican Republic
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University of VermontCompleted
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The Cleveland ClinicThe Honor Project TrustCompleted
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Potentia Pharmaceuticals, Inc.CompletedAge-Related Macular DegenerationUnited States
-
Children's Hospital Medical Center, CincinnatiCompleted
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Fundacion para la Investigacion Biomedica del Hospital...Withdrawn
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Centre Hospitalier FH ManhesRecruitingImpact of Cooking Workshops on Obese AdultsFrance
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University of MinnesotaCompletedChange in Dietary OutcomesUnited States
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Hadassah Medical OrganizationWithdrawn