Anemia
Conditions
Keywords
micronutrients
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.
Interventions
DIETARY_SUPPLEMENTSPRINKLES
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.
BEHAVIORALNutrition education
Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
Sponsors
Micronutrient Initiative
M/S SEBCON
Pakistan Ministry of Health
National Programme of Family Planning and Primary Health Care
Aga Khan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anemia | 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) |
| Number of Participants With Moderate to Severe Anemia | 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 |
| Mean Hemoglobin of Participants Post Intervention | Endline Hb taken 4-5 months post enrollment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Stunted Growth | 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 |
| Vitamin A Status of Participants - Post Intervention | Measurement taken 4-5 months post enrollment | Categorized as \<20ug/dL; 20-40 ug/dL; \>40 ug/dl |
| Percentage of Participants With Wasted Growth | Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment | Wasted defined as Weight for Height Z-score \< -2SD |
| Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention | Measurement taken 4-5 months post enrollment | — |
| Percentage of Underweight Participants | 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) |
Countries
Pakistan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 308 |
| 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. | 302 |
| Total | 610 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Migration due to political unrest | 21 | 15 |
Baseline characteristics
| Characteristic | Sprinkle-Advice | Advice Only | Total |
|---|---|---|---|
| Age, Continuous | 12 months STANDARD_DEVIATION 3.2 | 12.3 months STANDARD_DEVIATION 3.3 | 12.2 months STANDARD_DEVIATION 3.3 |
| Sex: Female, Male Female | 172 Participants | 155 Participants | 327 Participants |
| Sex: Female, Male Male | 136 Participants | 147 Participants | 283 Participants |
Outcome results
Primary
Mean Hemoglobin of Participants Post Intervention
Time frame: Endline Hb taken 4-5 months post enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sprinkle-Advice | Mean Hemoglobin of Participants Post Intervention | 10.97 g/dL |
| Advice Only | Mean Hemoglobin of Participants Post Intervention | 9.98 g/dL |
p-value: 0ANOVA
Primary
Number of Participants With Anemia
number with mild to severe anemia (hemoglobin(Hb)\<11g/dL)
Time frame: Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprinkle-Advice | Number of Participants With Anemia | Baseline anemia prevalence | 185 participants |
| Sprinkle-Advice | Number of Participants With Anemia | Endline anemia prevalence | 139 participants |
| Advice Only | Number of Participants With Anemia | Baseline anemia prevalence | 172 participants |
| Advice Only | Number of Participants With Anemia | Endline anemia prevalence | 191 participants |
p-value: 0.32Chi-squared
p-value: <0.001Chi-squared
Primary
Number of Participants With Moderate to Severe Anemia
number of participants with moderate - severe anemia defined as Hb \< 10g/dL
Time frame: Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprinkle-Advice | Number of Participants With Moderate to Severe Anemia | Baseline | 114 participants |
| Sprinkle-Advice | Number of Participants With Moderate to Severe Anemia | Endline | 84 participants |
| Advice Only | Number of Participants With Moderate to Severe Anemia | Baseline | 102 participants |
| Advice Only | Number of Participants With Moderate to Severe Anemia | Endline | 138 participants |
p-value: 0.34Chi-squared
p-value: <0.001Chi-squared
Secondary
Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention
Time frame: Measurement taken 4-5 months post enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sprinkle-Advice | Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention | 31.8 ug/dl |
| Advice Only | Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention | 25.1 ug/dl |
p-value: <0ANOVA
Secondary
Percentage of Participants With Stunted Growth
Stunted defined as Height for Age Z-score \< -2 standard deviation
Time frame: Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment
Population: Those who had complete anthropometric measurements at endline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprinkle-Advice | Percentage of Participants With Stunted Growth | Baseline Stunted % | 55 percentage of participants |
| Sprinkle-Advice | Percentage of Participants With Stunted Growth | Endline Stunted % | 62 percentage of participants |
| Advice Only | Percentage of Participants With Stunted Growth | Baseline Stunted % | 57 percentage of participants |
| Advice Only | Percentage of Participants With Stunted Growth | Endline Stunted % | 61 percentage of participants |
p-value: 0.62Chi-squared
p-value: 0.89Chi-squared
Secondary
Percentage of Participants With Wasted Growth
Wasted defined as Weight for Height Z-score \< -2SD
Time frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
Population: those who had complete anthropometric measurements at endline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprinkle-Advice | Percentage of Participants With Wasted Growth | Baseline Wasted % | 24 percentage of participants |
| Sprinkle-Advice | Percentage of Participants With Wasted Growth | Endline Wasted % | 13 percentage of participants |
| Advice Only | Percentage of Participants With Wasted Growth | Baseline Wasted % | 24 percentage of participants |
| Advice Only | Percentage of Participants With Wasted Growth | Endline Wasted % | 15 percentage of participants |
p-value: 0.93Chi-squared
p-value: 0.49Chi-squared
Secondary
Percentage of Underweight Participants
Underweight defined as Weight for Age Z score \< -2 standard deviation (SD)
Time frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
Population: those who had complete baseline anthropometric measures
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprinkle-Advice | Percentage of Underweight Participants | Baseline Underwt % | 49 percentage of participants |
| Sprinkle-Advice | Percentage of Underweight Participants | Endline Underwt % | 35 percentage of participants |
| Advice Only | Percentage of Underweight Participants | Baseline Underwt % | 48 percentage of participants |
| Advice Only | Percentage of Underweight Participants | Endline Underwt % | 44 percentage of participants |
p-value: 0.7Chi-squared
p-value: 0.02Chi-squared
Secondary
Vitamin A Status of Participants - Post Intervention
Categorized as \<20ug/dL; 20-40 ug/dL; \>40 ug/dl
Time frame: Measurement taken 4-5 months post enrollment
Population: those who had endline assessment of serum vitamin A
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprinkle-Advice | Vitamin A Status of Participants - Post Intervention | Low (<20 ug/dl) | 74 participants |
| Sprinkle-Advice | Vitamin A Status of Participants - Post Intervention | Moderate (20-40 ug/dl) | 96 participants |
| Sprinkle-Advice | Vitamin A Status of Participants - Post Intervention | High (>40 ug/dl) | 62 participants |
| Advice Only | Vitamin A Status of Participants - Post Intervention | Low (<20 ug/dl) | 115 participants |
| Advice Only | Vitamin A Status of Participants - Post Intervention | Moderate (20-40 ug/dl) | 89 participants |
| Advice Only | Vitamin A Status of Participants - Post Intervention | High (>40 ug/dl) | 28 participants |