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Iron Deficiency Anemia and Psychosocial Stimulation (IDA)

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ClinicalTrials.gov Identifier: NCT00668694
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : July 12, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
In developing countries, poor nutrition, high morbidity, poverty, poor parental education and stimulation in the home, all detrimentally affect children's development. These conditions frequently occur together increasing the risk of poor development. Iron deficiency anemia (IDA) affects large numbers of young children and is associated with poor child development. There is some question as to whether infants with IDA can catch up in mental development to non-IDA infants. We plan to examine the effect of psychosocial stimulation on IDA children's growth and development using a randomized controlled trial and compare them with non-anemic children. The study will be located in poor villages accessible to Dhaka. Villages will be randomized to either receive psychosocial stimulation or none. Children, aged 6-12 months, with IDA (hemoglobin (Hb) 80.0-109g/L, ferritin<12μg/L & Transferrin Recepter (TfR) >7) (n=212) or without anemia (Hb>109g/L, ferritin>12μg/L, C-reactive protein (CRP) <5 & TfR<7) (n=212) will be identified in those villages. Intervention will include weekly home visits for 9 months by a play leader, who will demonstrate play with home made toys and teach the mothers about child development. All IDA children will be given 30 mg ferrous-sulphate daily for 9 months. At the beginning and end of the study, the following measurements will be made: Bayley Scales of Infant Development (mental and motor indices), Wolke's behavior ratings, Hb, serum ferritin, CRP, Transferrin receptor, anthropometry, home stimulation, and mothers' knowledge and practices of child development. Stool microscopy, maternal-urinary iodine (as a proxy to assess children's iodine status), dietary history, child rearing practices (parenting) of mothers, perinatal history and socioeconomic conditions will be assessed at the beginning and children's language development at the end. Depending on availability of funds serum TSH will also be measured in children to exclude iodine deficiency. We will also measure mothers' nutritional and mental status to assess its relationship with children's development. The treatment effect will be examined by intention to treat analysis using multiple regression of the outcome variables controlling for initial measures and multilevel analysis will be conducted to control for differences at village level. The findings of this project will have implications both for international and national policies on early childhood development programs for IDA children.

Condition or disease Intervention/treatment
Iron Deficiency Anemia Behavioral: Stimulation

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Psychosocial Stimulation on Development of Iron-deficient Anemic Infants: A Randomized Controlled Trial
Study Start Date : October 2007
Primary Completion Date : December 2008
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
Anemia without stimulation.
Experimental: 2
Anemia with stimulation
Behavioral: Stimulation
Stimulation given to the child by mother
No Intervention: 3
Non-anemic group: Hb >80-109 g/L ferritin levels >12 μg/L and TfR <6 will be enrolled without stimulation
No Intervention: 4
Non-anemic group: Hb >80-109 g/L ferritin levels >12 μg/L and TfR <6 will be enrolled with stimulation


Outcome Measures

Primary Outcome Measures :
  1. Mental and motor development. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Anthropometry [ Time Frame: 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All children will be aged 6 to 24 months, living in the defined rural area and have parental consent to join the study

Exclusion Criteria:

  • The following children will be excluded:

    • those with multiple births
    • congenital abnormalities
    • Bayley scores <55
    • Hb<80 g/L or severe wasting (weight for height <-3 z score)
  • Children with severe wasting or Hb<80 g/L will be referred to the Thana Health Complex for treatment.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668694


Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Dhaka, Bangladesh
Institute of Child Health
Penn State University
More Information

Responsible Party: Dr. Jena D. Hamadani, Scientist, ICDDR,B
ClinicalTrials.gov Identifier: NCT00668694     History of Changes
Other Study ID Numbers: 2007-040
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: April 2008

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Psychosocial stimulation in addition to iron supplementation will improve mental and psychomotor development, language, behavior and growth of IDA infants.
With the addition of stimulation IDA infants will catch up to the non-anemic infants.

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders