Iron Deficiency Anemia and Psychosocial Stimulation

NCT00668694 | Completed

• 1 other identifier: 2007-040
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia

Keywords

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.

Outcome Measures

Primary Outcomes (1)

• Mental and motor development.

  9 months

Secondary Outcomes (1)

• Anthropometry

  9 months

Study Arms (4)

1

NO INTERVENTION

Anemia without stimulation.

2

EXPERIMENTAL

Anemia with stimulation

Behavioral: Stimulation

3

NO INTERVENTION

Non-anemic group: Hb \>80-109 g/L ferritin levels \>12 μg/L and TfR \<6 will be enrolled without stimulation

4

NO INTERVENTION

Non-anemic group: Hb \>80-109 g/L ferritin levels \>12 μg/L and TfR \<6 will be enrolled with stimulation

Interventions

Stimulation BEHAVIORAL

Stimulation given to the child by mother

2

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• University of Dhaka, Bangladesh: collaborator
• Institute of Child Health: collaborator
• Penn State University: collaborator

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Tofail F, Hamadani JD, Mehrin F, Ridout DA, Huda SN, Grantham-McGregor SM. Psychosocial stimulation benefits development in nonanemic children but not in anemic, iron-deficient children. J Nutr. 2013 Jun;143(6):885-93. doi: 10.3945/jn.112.160473. Epub 2013 Apr 24.

  PMID: 23616511 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Language; Behavior

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2008
• First Posted: April 29, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: September 1, 2009
• Last Updated: May 30, 2018

Record last verified: 2008-04

Locations

BA (1)