AnemiaSprinklesNCT00659061
Monitoring and Evaluation of Micronutrients (Sprinkles) Project
A study testing SPRINKLES and Nutrition education in people with Anemia, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- SPRINKLES and Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2007to May 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- SPRINKLES, Nutrition education
- Keywords
- micronutrients
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPRINKLESDietary supplement
Also called Multiple micronutrient fortificant
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.
Nutrition educationBehavioural
Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs. Receives: Dietary Supplement: SPRINKLES; Behavioral: Nutrition education |
| Control | No intervention | Routine public health massages by Lady Health Workers (LHWs) during their community visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Anemia
number with mild to severe anemia (hemoglobin(Hb)<11g/dL)
Measured: 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
Measured: Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
Mean Hemoglobin of Participants Post Intervention
Measured: Endline Hb taken 4-5 months post enrollment
Secondary outcomes (5)
Vitamin A Status of Participants - Post Intervention
Categorized as <20ug/dL; 20-40 ug/dL; >40 ug/dl
Measured: Measurement taken 4-5 months post enrollment
Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention
Measured: Measurement taken 4-5 months post enrollment
Percentage of Underweight Participants
Underweight defined as Weight for Age Z score < -2 standard deviation (SD)
Measured: 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
Measured: 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
Measured: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Micronutrient Initiative, M/S SEBCON, Pakistan Ministry of Health, National Programme of Family Planning and Primary Health Care
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar A Bhutta, MD, PhD, Study chair, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659061
- Sponsor's protocol ID
- 754-Ped/ERC-07
- Acronym
- Sprinkles
- Status last verified
- Jan 2018
- First submitted
- 14 Apr 2008
- Last updated
- 1 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Evaluation of Micronutrients (Sprinkles) Project
- ClinicalTrials.gov ID
- NCT00659061
- Acronym / sponsor ID
- Sprinkles / 754-Ped/ERC-07
- Conditions
- Anemia
- Keywords
- micronutrients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Micronutrient Initiative, M/S SEBCON, Pakistan Ministry of Health, National Programme of Family Planning and Primary Health Care
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 27 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: SPRINKLES, Behavioral: Nutrition educationMultiple 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. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPRINKLESAlso: Multiple micronutrient fortificantSprinkles 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. | Dietary supplement | Intervention |
| Nutrition educationNutrition education will be provided by LHWs as per their regular routine monthly door to door community services | Behavioural | Intervention |
Primary outcome
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)
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
number of participants with moderate - severe anemia defined as Hb < 10g/dL
Mean Hemoglobin of Participants Post Intervention
Time frame: Endline Hb taken 4-5 months post enrollment
5 secondary outcomes
Vitamin A Status of Participants - Post Intervention
Time frame: Measurement taken 4-5 months post enrollment
Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention
Time frame: 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
Percentage of Participants With Stunted Growth
Time frame: Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment
Percentage of Participants With Wasted Growth
Time frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfiqar A Bhutta, MD, PhD study chair
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPRINKLES and Nutrition education in people with Anemia, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Anemia (time frame: Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.