NCT02801721

Brief Summary

  • 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

June 5, 2016

Last Update Submit

June 29, 2016

Conditions

Anaemia

Outcome Measures

Primary Outcomes (1)

  • Cognitive ability

    We will use The Wechsler Abbreviated Scale of Intelligence (WASI) for measuring the cognitive ability. It consists of four subtests: Vocabulary, Block Design, Similarities and Matrix Reasoning. Scores of these subtests lead to calculate performance IQ (PIQ), verbal IQ (VIQ) as well as a full scale IQ (FSIQ). FSIQ will measure the cognitive ability.

    single time point at follow up after an average of 6 years of the original study

Secondary Outcomes (15)

  • School achievement

    single time point at follow up after an average of 6 years of the original study

  • Number Stroop

    single time point at follow up after an average of 6 years of the original study

  • Strength and difficulties questionnaire (SDQ)

    single time point at follow up after an average of 6 years of the original study

  • Memory subtests of NEuroPSYchological (NEPSY) Assessment

    single time point at follow up after an average of 6 years of the original study

  • Digit span

    single time point at follow up after an average of 6 years of the original study

  • +10 more secondary outcomes

Study Arms (2)

Stimulation

ACTIVE COMPARATOR

Stimulation group received psycho social stimulation. In the stimulation there were anemic and non anemic children. All anemic children received iron(syrup) supplementation.

Other: psycho social stimulation

No stimulation

NO INTERVENTION

No stimulation group did not receive any stimulation. In the no stimulation group there were anemic and non anemic children. All anemic children received iron (syrup) supplementation

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.

Stimulation

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All non anaemic children
  • Anaemic children (Haemoglobin concentration .80g/L and ,110g/L) and
  • Serum transferrin receptor concentration ≥ 5.0mg/L

You may not qualify if:

  • Twin Baby
  • Children with known hematological diseases
  • Children with known chronic diseases
  • Refused concent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Bodnar LM, Cogswell ME, McDonald T. Have we forgotten the significance of postpartum iron deficiency? Am J Obstet Gynecol. 2005 Jul;193(1):36-44. doi: 10.1016/j.ajog.2004.12.009.

    PMID: 16021056RESULT

  • Benton D; ILSI Europe a.i.s.b.l. Micronutrient status, cognition and behavioral problems in childhood. Eur J Nutr. 2008 Aug;47 Suppl 3:38-50. doi: 10.1007/s00394-008-3004-9.

    PMID: 18683028RESULT

  • Black MM, Baqui AH, Zaman K, Ake Persson L, El Arifeen S, Le K, McNary SW, Parveen M, Hamadani JD, Black RE. Iron and zinc supplementation promote motor development and exploratory behavior among Bangladeshi infants. Am J Clin Nutr. 2004 Oct;80(4):903-10. doi: 10.1093/ajcn/80.4.903.

    PMID: 15447897RESULT

  • Bryan J, Osendarp S, Hughes D, Calvaresi E, Baghurst K, van Klinken JW. Nutrients for cognitive development in school-aged children. Nutr Rev. 2004 Aug;62(8):295-306. doi: 10.1111/j.1753-4887.2004.tb00055.x.

    PMID: 15478684RESULT

  • Friel JK, Aziz K, Andrews WL, Harding SV, Courage ML, Adams RJ. A double-masked, randomized control trial of iron supplementation in early infancy in healthy term breast-fed infants. J Pediatr. 2003 Nov;143(5):582-6. doi: 10.1067/S0022-3476(03)00301-9.

    PMID: 14615726RESULT

  • Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.

    PMID: 11699809RESULT

  • Grantham-McGregor SM, Lira PI, Ashworth A, Morris SS, Assuncao AM. The development of low birth weight term infants and the effects of the environment in northeast Brazil. J Pediatr. 1998 Apr;132(4):661-6. doi: 10.1016/s0022-3476(98)70357-9.

    PMID: 9580767RESULT

  • Huda SN, Grantham-McGregor SM, Rahman KM, Tomkins A. Biochemical hypothyroidism secondary to iodine deficiency is associated with poor school achievement and cognition in Bangladeshi children. J Nutr. 1999 May;129(5):980-7. doi: 10.1093/jn/129.5.980.

    PMID: 10222389RESULT

  • Huda SN, Grantham-McGregor SM, Tomkins A. Cognitive and motor functions of iodine-deficient but euthyroid children in Bangladesh do not benefit from iodized poppy seed oil (Lipiodol). J Nutr. 2001 Jan;131(1):72-7. doi: 10.1093/jn/131.1.72.

    PMID: 11208941RESULT

  • Lind T, Lonnerdal B, Stenlund H, Gamayanti IL, Ismail D, Seswandhana R, Persson LA. A community-based randomized controlled trial of iron and zinc supplementation in Indonesian infants: effects on growth and development. Am J Clin Nutr. 2004 Sep;80(3):729-36. doi: 10.1093/ajcn/80.3.729.

    PMID: 15321815RESULT

  • Lozoff B, Jimenez E, Wolf AW. Long-term developmental outcome of infants with iron deficiency. N Engl J Med. 1991 Sep 5;325(10):687-94. doi: 10.1056/NEJM199109053251004.

    PMID: 1870641RESULT

  • Low M, Farrell A, Biggs BA, Pasricha SR. Effects of daily iron supplementation in primary-school-aged children: systematic review and meta-analysis of randomized controlled trials. CMAJ. 2013 Nov 19;185(17):E791-802. doi: 10.1503/cmaj.130628. Epub 2013 Oct 15.

    PMID: 24130243RESULT

  • Ruel MT, Alderman H; Maternal and Child Nutrition Study Group. Nutrition-sensitive interventions and programmes: how can they help to accelerate progress in improving maternal and child nutrition? Lancet. 2013 Aug 10;382(9891):536-51. doi: 10.1016/S0140-6736(13)60843-0. Epub 2013 Jun 6.

    PMID: 23746780RESULT

  • Thompson J, Biggs BA, Pasricha SR. Effects of daily iron supplementation in 2- to 5-year-old children: systematic review and meta-analysis. Pediatrics. 2013 Apr;131(4):739-53. doi: 10.1542/peds.2012-2256. Epub 2013 Mar 11.

    PMID: 23478873RESULT

  • 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: 23616511RESULT

  • Walker SP, Wachs TD, Grantham-McGregor S, Black MM, Nelson CA, Huffman SL, Baker-Henningham H, Chang SM, Hamadani JD, Lozoff B, Gardner JM, Powell CA, Rahman A, Richter L. Inequality in early childhood: risk and protective factors for early child development. Lancet. 2011 Oct 8;378(9799):1325-38. doi: 10.1016/S0140-6736(11)60555-2. Epub 2011 Sep 22.

    PMID: 21944375RESULT

  • Hossain SJ, Tofail F, Mehrin SF, Hamadani JD. Six-Year Follow-up of Childhood Stimulation on Development of Children With and Without Anemia. Pediatrics. 2023 May 1;151(Suppl 2):e2023060221E. doi: 10.1542/peds.2023-060221E.

    PMID: 37125884DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2016

First Posted

June 16, 2016

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

if required we will share data with our expert