Monitoring and Evaluation of Micronutrients (Sprinkles) Project

Study Overview
=================
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.

Official Title
-----------------
Monitoring and Evaluation of Micronutrients (Sprinkles) Project

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Dietary Supplement: SPRINKLES
* Behavioral: Nutrition education


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs. | Dietary Supplement: SPRINKLES<br>* 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.<br>* Other names: Multiple micronutrient fortificant;Behavioral: Nutrition education<br>* Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services<br>|
| No Intervention: Control<br>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 | 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 | 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 |  | Endline Hb taken 4-5 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin A Status of Participants - Post Intervention | 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 |  | Measurement taken 4-5 months post enrollment | 
| Percentage of Underweight Participants | 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 | 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 | Wasted defined as Weight for Height Z-score < -2SD | Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
micronutrients