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Monitoring and Evaluation of Micronutrients (Sprinkles) Project

A

Aga Khan University

Status

Completed

Conditions

Anemia

Treatments

Behavioral: Nutrition education
Dietary Supplement: SPRINKLES

Study type

Interventional

Funder types

Other

Identifiers

NCT00659061
754-Ped/ERC-07

Details and patient eligibility

About

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.

Full 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.

Enrollment

610 patients

Sex

All

Ages

6 to 18 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

610 participants in 2 patient groups

Intervention
Active Comparator group
Description:
Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.
Treatment:
Behavioral: Nutrition education
Dietary Supplement: SPRINKLES
Control
No Intervention group
Description:
Routine public health massages by Lady Health Workers (LHWs) during their community visits.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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