- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659061
Monitoring and Evaluation of Micronutrients (Sprinkles) Project (Sprinkles)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sindh
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Naushero Feroze, Sindh, Pakistan
- AKU-Peds Naushero Feroze Site Office
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
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No Intervention: Control
Routine public health massages by Lady Health Workers (LHWs) during their community visits.
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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)
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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
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number of participants with moderate - severe anemia defined as Hb < 10g/dL
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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
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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
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Underweight defined as Weight for Age Z score < -2 standard deviation (SD)
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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
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Stunted defined as Height for Age Z-score < -2 standard deviation
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Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment
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Percentage of Participants With Wasted Growth
Time Frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
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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
Sponsor
Collaborators
Investigators
- Study Chair: Zulfiqar A Bhutta, MD, PhD, Aga Khan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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