Trial record 9 of 304 for:    iron-deficiency anemia

Effect of Consuming Food Cooked in Iron Utensils on Iron Status in Children With Iron Deficiency Anemia (IDA)

This study has been completed.
Sponsor:
Collaborator:
Sir Gangadharrao Chitnavis Memorial Medical Research Trust Nagpur
Information provided by:
Dhande, Leena Ajay, M.D.
ClinicalTrials.gov Identifier:
NCT01115023
First received: April 30, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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."


Condition Intervention
Iron Deficiency Anemia
Other: iron cooking pot

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Dhande, Leena Ajay, M.D.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iron group
This group received an iron cooking pot for daily household cooking as an intervention
Other: iron cooking pot
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.
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.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inclusion criteria

  1. Age: 2-12 years,
  2. Resident of urban Nagpur
  3. Diagnosed as having non-severe IDA defined as Hb% > 5gm% but less than cut off point for age for diagnosing anemia.

Exclusion Criteria:

  1. Suffering from Hemoglobinopathy or Iron overload due to any cause
  2. Receiving Iron therapy
  3. Malabsorption
  4. Bleeding diathesis
  5. Chronic illness
  6. Participation in another trial in last 30 days
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01115023

Locations
India
Government Medical College
Nagpur, Maharashtra, India, 440003
Sponsors and Collaborators
Dhande, Leena Ajay, M.D.
Sir Gangadharrao Chitnavis Memorial Medical Research Trust Nagpur
Investigators
Principal Investigator: Leena Ajay Dhande, MD (Pediatrics) Associate Professor
  More Information

No publications provided

Responsible Party: Leena Ajay Dhande, Indira Gandhi Govt Medical College, Nagpur
ClinicalTrials.gov Identifier: NCT01115023     History of Changes
Other Study ID Numbers: L1IDA1
Study First Received: April 30, 2010
Last Updated: April 30, 2010
Health Authority: India: Ministry of Health

Keywords provided by Dhande, Leena Ajay, M.D.:
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.

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Anemia, Hypochromic
Deficiency Diseases
Hematologic Diseases
Malnutrition
Nutrition Disorders
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014