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| Name | Class |
|---|---|
| Micronutrient Initiative | OTHER |
| M/S SEBCON | OTHER |
| Pakistan Ministry of Health | OTHER_GOV |
| National Programme of Family Planning and Primary Health Care |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs. |
|
| Control | No Intervention | Routine public health massages by Lady Health Workers (LHWs) during their community visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPRINKLES | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zulfiqar A Bhutta, MD, PhD | Aga Khan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKU-Peds Naushero Feroze Site Office | Naushero Feroze | Sindh | Pakistan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sprinkle-Advice | Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits. |
| FG001 | Advice Only | Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sprinkle-Advice | Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits. |
| BG001 | Advice Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Anemia | number with mild to severe anemia (hemoglobin(Hb)<11g/dL) | Posted | Number | participants | Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment |
|
The attrition rate was high (6.8% in intervention group and 5.0% in the control group) due to unforeseen migration because of political unrest in the region.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Zulfiqar Ahmed Bhutta | Aga Khan University | 4930051 | 4782 | zulfiqar.bhutta@aku.edu |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| UNKNOWN |
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|
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| Nutrition education | Behavioral | Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services |
|
| 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 |
Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
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|
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| Secondary | Vitamin A Status of Participants - Post Intervention | Categorized as <20ug/dL; 20-40 ug/dL; >40 ug/dl | those who had endline assessment of serum vitamin A | Posted | Number | participants | Measurement taken 4-5 months post enrollment |
|
|
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| Secondary | Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention | Posted | Mean | 95% Confidence Interval | ug/dl | Measurement taken 4-5 months post enrollment |
|
|
|
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| Primary | Number of Participants With Moderate to Severe Anemia | number of participants with moderate - severe anemia defined as Hb < 10g/dL | Posted | Number | participants | Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment |
|
|
|
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| Primary | Mean Hemoglobin of Participants Post Intervention | Posted | Mean | 95% Confidence Interval | g/dL | Endline Hb taken 4-5 months post enrollment |
|
|
|
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| Secondary | Percentage of Underweight Participants | Underweight defined as Weight for Age Z score < -2 standard deviation (SD) | those who had complete baseline anthropometric measures | Posted | Number | percentage of participants | Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment |
|
|
|
|
| Secondary | Percentage of Participants With Stunted Growth | Stunted defined as Height for Age Z-score < -2 standard deviation | Those who had complete anthropometric measurements at endline | Posted | Number | percentage of participants | Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment |
|
|
|
|
| Secondary | Percentage of Participants With Wasted Growth | Wasted defined as Weight for Height Z-score < -2SD | those who had complete anthropometric measurements at endline | Posted | Number | percentage of participants | Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment |
|
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| High (>40 ug/dl) |
|
endline
| 95 |
| Superiority or Other |
endline
| 95 |
| Superiority or Other |
endline
| 95 |
| Superiority or Other |
endline
| 95 |
| Superiority or Other |