Monitoring and Evaluation of Micronutrients (Sprinkles) Project
NCT ID: NCT00659061
Last Updated: 2018-02-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
610 participants
INTERVENTIONAL
2007-08-31
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan
NCT03287882
Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan
NCT06009198
Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children
NCT03450174
Effect of Maternal Supplementation From Preconception to Lactation on Child Growth and Development
NCT06641349
Appropriate Complmentary Feeding Strategies in Infants
NCT01412411
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.
SPRINKLES
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 education
Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
Control
Routine public health massages by Lady Health Workers (LHWs) during their community visits.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPRINKLES
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 education
Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Random selection of child in household with more than one eligible child
Exclusion Criteria
* 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
6 Months
18 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Micronutrient Initiative
OTHER
M/S SEBCON
OTHER
Pakistan Ministry of Health
OTHER_GOV
National Programme of Family Planning and Primary Health Care
UNKNOWN
Aga Khan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Zulfiqar Ahmed Bhutta
Founding Director, Centre of Excellence in Women and Child Health
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zulfiqar A Bhutta, MD, PhD
Role: STUDY_CHAIR
Aga Khan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AKU-Peds Naushero Feroze Site Office
Naushero Feroze, Sindh, Pakistan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
754-Ped/ERC-07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.