CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 349 enrolled
Drug / intervention
psycho social stimulationother
Likely dose
Not stated in record
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Search/NCT02801721
NCT02801721N/ACompleted

Long Term Effect of Early Iron Supplementation and Psychosocial Stimulation on Growth and Development of Iron-deficient Anaemic Infants

International Centre for Diarrhoeal Disease Research, Bangladesh·interventional·Posted Jun 16, 2016·Updated Jun 30, 2016

In Brief

A clinical study evaluating psycho social stimulation for Anaemia. Completed, enrolled 349 participants.

Detailed Summary

1. Burden: Anaemia is a public health problem in our country. Fifty one percent young children aged 6 to 59 months are suffering from anaemia in Bangladesh (BDHS-2011) and the main cause of this problem is iron deficiency. Research findings show that Iron deficiency leads to delayed development and even reduce working capacity. All these impact negatively on quality of life and loss of national gross domestic product (GDP). 2. Knowledge gap: Little is known about long-term effects of early life iron deficiency anemia on development and behaviour of children after correction with iron supplements. There is also scarcity of information if early life psychosocial stimulation added to iron supplementation to these anemic children have long term benefits compared to non-stimulated anaemic children or non-anaemic children 3. Relevance: The aim was to conduct a follow up study to examine whether the IDA children, who recovered from iron deficiency and received additional more intense psychosocial intervention catch up to their optimum development in later life at school age, similar like non-anaemic peers. 4. Hypothesis (if any): 1. The benefit of early iron supplementation in addition to Psychosocial stimulation on growth and development of IDA infants appears in later life. 2. Addition of early psychosocial stimulation in treated IDA children help them catch up to their non-anemic peers in development over time. 5. Study Objective(s) 1. To determine the long term effect of early psychosocial stimulation provided at the age of 6-24 months in addition to iron treatment in IDA children on their growth (height, weight and Head Circumference), IQ, executive function, school achievement, fine motor, memory and behaviour 2. To compare the growth and development of IDA infants with non-anemic infants after 7 years of an intervention with iron supplementation and psychosocial stimulation. 6. Methods: Sample: All children who participated in the iron and stimulation study at the age of 6 to 24 months (n=424). Identification of sample: Using the addresses and by tracking through available mobile phone numbers. Measurements In the current follow-up, at the age of around 8-9 years all the available children will be measured for: * WASI: The Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) * School achievement * Number Stroop * SDQ (strength and difficulties):The Strengths and Difficulties Questionnaire (SDQ) * Memory test of NEPSY (neuropsychological test) * Digit span forward and backward * Middle childhood HOME * Fine motor skills using the Purdue peg board or Movement Assessment Battery Children- 2 (age -band 2 for 7-10 years) * SES Anthropometric measurement: Children's height, weight and head circumference

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaemia
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 16, 2016
Enrollment StartJul 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.0 years ago

Interventions

psycho social stimulationother

The psychosocial intervention lasted for 9 months and included play demonstrations at home by a play leader (PL) who was trained to visit homes and teach the mothers about child development and care practices. They also showed the mothers how to play with children using toys in a way to promote good child development. In the original study all anemic children in early childhood received 30 mg ferrous sulphate daily based on recommendations from both the WHO (2003) and IOM reports (2001) for 6 months.