NCT01412411

Brief Summary

The purpose of this study has been to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods. In this community based randomized clinical trial, the nutrition education package implemented aimed to improve hematological parameters including the micronutrient status and to see effect on growth indicators.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
470

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
Last Updated

August 9, 2011

Status Verified

March 1, 2008

Enrollment Period

2.7 years

First QC Date

August 3, 2011

Last Update Submit

August 8, 2011

Conditions

Keywords

AnemiaGrowthInfantsFocus of the study is to assess the level of anemia and growth indicators among the infants

Outcome Measures

Primary Outcomes (1)

  • Anemia

    To assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators

    12 months

Secondary Outcomes (3)

  • Compliance to intake of study medicines

    12 months

  • Morbidity Assessment

    12 months

  • Developmental Assessment

    12 months

Study Arms (3)

Nutrition Education plus Multiple Micronutrient Fortification

ACTIVE COMPARATOR

In this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles

Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education

OIS plus Nutritional Eductaion

ACTIVE COMPARATOR

In this group, along with the nutritional education, Oral Iron Supplementation was given.

Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion

Nutrition Education Group

ACTIVE COMPARATOR

This is group was followed for the growth of the child and was given Nutritional Education to children's mothers.

Behavioral: Nutritionl Education

Interventions

to assess the change in behaviour

Nutrition Education Group
OIS plus Nutritional Eductaion
Nutrition Education plus Multiple Micronutrient Fortification

Eligibility Criteria

Age6 Months - 8 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children between the age of 6 months to 8 months.

You may not qualify if:

  • Children who are sick to an extent that cannot take anythign oral were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilal Colony Centre

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Anemia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Aziz AJ Abdul Rehman Jiwani, MBBS, PhD

    Aga Khan University

    PRINCIPAL INVESTIGATOR
  • Zulfiqar ZB Bhuta, MBBS, MCPS (Peds), FCPS (Peds)

    Aga Khan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 9, 2011

Study Start

October 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

August 9, 2011

Record last verified: 2008-03

Locations