Iron Deficiency Anemia and Psychosocial Stimulation (IDA)

This study has been completed.
Sponsor:
Collaborators:
University of Dhaka, Bangladesh
Institute of Child Health
Penn State University
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00668694
First received: April 27, 2008
Last updated: July 11, 2011
Last verified: April 2008
  Purpose

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 Intervention
Iron Deficiency Anemia
Behavioral: Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Psychosocial Stimulation on Development of Iron-deficient Anemic Infants: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Mental and motor development. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anthropometry [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 424
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Jena D. Hamadani, Scientist, ICDDR,B
ClinicalTrials.gov Identifier: NCT00668694     History of Changes
Other Study ID Numbers: 2007-040
Study First Received: April 27, 2008
Last Updated: July 11, 2011
Health Authority: Bangladesh: Ethical Review Committee

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
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 27, 2014