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Monitoring and Evaluation of Micronutrients (Sprinkles) Project

Not Applicable
Completed
Conditions
Anemia
Interventions
Dietary Supplement: SPRINKLES
Behavioral: Nutrition education
Registration Number
NCT00659061
Lead Sponsor
Aga Khan University
Brief Summary

The purpose of this study is 1) to evaluate the effectiveness in reducing anemia among children 6-24 months of age by providing daily micronutrient Sprinkles through the Government of Pakistan's Lady Health Worker program; 2) to assist in the monitoring the National Sprinkles Pilot Project.

Detailed Description

According to the recent National Nutrition Survey in Pakistan (2001-2002), approximately 66.5% of children under five have anaemia.

Looking at the magnitude of the problem, National Program for Family Planning (FP) and Primary Health Care (PHC) (also known as the Lady Health Workers (LHW) Program) has developed National Sprinkles Pilot Project Proposal with technical assistance of Micronutrient Initiative and Aga Khan University (AKU). As the projects technical partner, AKU is responsible to conduct the monitoring and evaluation of the project.

The study will use a cluster randomized pre-post intervention design that compares before and after hemoglobin (Hb) measurements, serum ferritin, serum retinol and urinary iodine among children who received Sprinkles and age-appropriate feeding advice (Sprinkles-Advice group) and children who only receive age-appropriate feeding advice (Advice-only group). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits. However, intervention LHWs, will give additional advice regarding the benefits of Sprinkles and its appropriate use.

The target population selected for the study consisted of children between the ages of six and eighteen months of age in the catchment area of the Lady Health Workers.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
610
Inclusion Criteria
  • Child's mother gives written consent after hearing an explanation of the study
  • Random selection of child in household with more than one eligible child
Exclusion Criteria
  • Any household in which consent is not given
  • Children with any congenital or physical disability (such as cleft palate, Down's Syndrome, etc.)
  • Child from a family which intends to migrate during the study period

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionSPRINKLESMultiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.
InterventionNutrition educationMultiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Moderate to Severe AnemiaBaseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment

number of participants with moderate - severe anemia defined as Hb \< 10g/dL

Number of Participants With AnemiaBaseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment

number with mild to severe anemia (hemoglobin(Hb)\<11g/dL)

Mean Hemoglobin of Participants Post InterventionEndline Hb taken 4-5 months post enrollment
Secondary Outcome Measures
NameTimeMethod
Percentage of Underweight ParticipantsBaseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment

Underweight defined as Weight for Age Z score \< -2 standard deviation (SD)

Vitamin A Status of Participants - Post InterventionMeasurement taken 4-5 months post enrollment

Categorized as \<20ug/dL; 20-40 ug/dL; \>40 ug/dl

Percentage of Participants With Stunted GrowthBaseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment

Stunted defined as Height for Age Z-score \< -2 standard deviation

Mean Vitamin A Serum Retinol (ug]dl) Taken Post InterventionMeasurement taken 4-5 months post enrollment
Percentage of Participants With Wasted GrowthBaseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment

Wasted defined as Weight for Height Z-score \< -2SD

Trial Locations

Locations (1)

AKU-Peds Naushero Feroze Site Office

🇵🇰

Naushero Feroze, Sindh, Pakistan

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