Monitoring and Evaluation of Micronutrients (Sprinkles) Project (Sprinkles)

January 8, 2018 updated by: Dr Zulfiqar Ahmed Bhutta, Aga Khan University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

610

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sindh
      • Naushero Feroze, Sindh, Pakistan
        • AKU-Peds Naushero Feroze Site Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.

Sprinkles is a multiple micronutrient fortificant. It is packed as a single serving sachets each containing micro encapsulated iron (12.5 mg), zinc (7.5 mg), vitamin C (30 mg), vitamin A (300 µg), vitamin D (5 µg), folic acid (150 µg) and iodine (90µg).

Two month supply of the Sprinkle sachet along with advice on its benefits as well as its appropriate use will be given by the LHWs. The LHWs will also provide their age-appropriate nutritional advice as per their regular door to door community services.

Other Names:
  • Multiple micronutrient fortificant
Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
No Intervention: Control
Routine public health massages by Lady Health Workers (LHWs) during their community visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Anemia
Time Frame: Baseline 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)
Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
Number of Participants With Moderate to Severe Anemia
Time Frame: Baseline 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
Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
Mean Hemoglobin of Participants Post Intervention
Time Frame: Endline Hb taken 4-5 months post enrollment
Endline Hb taken 4-5 months post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin A Status of Participants - Post Intervention
Time Frame: Measurement taken 4-5 months post enrollment
Categorized as <20ug/dL; 20-40 ug/dL; >40 ug/dl
Measurement taken 4-5 months post enrollment
Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention
Time Frame: Measurement taken 4-5 months post enrollment
Measurement taken 4-5 months post enrollment
Percentage of Underweight Participants
Time Frame: Baseline 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)
Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
Percentage of Participants With Stunted Growth
Time Frame: Baseline 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
Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment
Percentage of Participants With Wasted Growth
Time Frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
Wasted defined as Weight for Height Z-score < -2SD
Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Zulfiqar A Bhutta, MD, PhD, Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 754-Ped/ERC-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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