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

NCT01115023 | Completed

• 1 other identifier: L1IDA1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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."

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.

Outcome Measures

Primary Outcomes (1)

• to compare the rise in Hemoglobin at the end of 60 days period in the iron group vs the aluminium group.

  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.

  60 days

Study Arms (2)

iron group

EXPERIMENTAL

This group received an iron cooking pot for daily household cooking as an intervention

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.

Interventions

iron cooking pot OTHER

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.

iron group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dhande, Leena Ajay, M.D.: lead
• Sir Gangadharrao Chitnavis Memorial Medical Research Trust Nagpur: collaborator

Study Sites (1)

Government Medical College

Nagpur, Maharashtra, 440003, India

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Leena Ajay Dhande, MD (Pediatrics)

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 3, 2010
• Study Start: October 1, 2003
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: May 3, 2010

Record last verified: 2010-04

Locations

IN (1)