Clinical trial NCT00659061: Monitoring and Evaluation of Micronutrients (Sprinkles) Project
Official title: Monitoring and Evaluation of Micronutrients (Sprinkles) Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: micronutrients
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Micronutrient Initiative
name: M/S SEBCON
name: Pakistan Ministry of Health
name: National Programme of Family Planning and Primary Health Care
First posted: 2008-04-16
Enrollment: 610
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Anemia
timeFrame: Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
measure: Number of Participants With Moderate to Severe Anemia
timeFrame: Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
measure: Mean Hemoglobin of Participants Post Intervention
timeFrame: Endline Hb taken 4-5 months post enrollment
Secondary outcomes:
measure: Vitamin A Status of Participants - Post Intervention
timeFrame: Measurement taken 4-5 months post enrollment
measure: Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention
timeFrame: Measurement taken 4-5 months post enrollment
measure: Percentage of Underweight Participants
timeFrame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
measure: Percentage of Participants With Stunted Growth
timeFrame: Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment
measure: Percentage of Participants With Wasted Growth
timeFrame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
Other outcomes:
Locations:
city: Naushero Feroze
country: Pakistan
facility: AKU-Peds Naushero Feroze Site Office
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, MD, PhD
role: STUDY_CHAIR
References: