Monitoring and Evaluation of Micronutrients (Sprinkles) Project

This study has been completed.
Sponsor:
Collaborators:
MicroNutrient Initiative
M/S SEBCON
Pakistan Ministry of Health
National Programme of Family Planning and Primary Health Care
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00659061
First received: April 14, 2008
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Anemia
Dietary Supplement: SPRINKLES
Behavioral: Advice only

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Monitoring and Evaluation of Micronutrients (Sprinkles) Project

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Number of Participants With Anemia [ Time Frame: Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean Hemoglobin of Participants Post Intervention [ Time Frame: Endline Hb taken 4-5 months post enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vitamin A Status of Participants - Post Intervention [ Time Frame: Measurement taken 4-5 months post enrollment ] [ Designated as safety issue: No ]
  • Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention [ Time Frame: Measurement taken 4-5 months post enrollment ] [ Designated as safety issue: No ]
  • Percentage of Underweight Participants [ Time Frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment ] [ Designated as safety issue: No ]
  • Percentage of Participants With Stunted Growth [ Time Frame: Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment ] [ Designated as safety issue: No ]
  • Percentage of Participants With Wasted Growth [ Time Frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment ] [ Designated as safety issue: No ]

Enrollment: 610
Study Start Date: August 2007
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sprinkle-Advice
Multiple micronutrient fortificant (Sprinkles) and age-appropriate feeding advice given by LHWs. Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Dietary Supplement: 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.

Other Name: multiple micronutrient fortificant
Behavioral: Advice only
No sprinkle sachets will be given by the LHW. However, the LHWs will provide the age-appropriate nutritional advice as per their regular routine monthly door to door community services
Other Name: nutrition education
No Intervention: 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.
Behavioral: Advice only
No sprinkle sachets will be given by the LHW. However, the LHWs will provide the age-appropriate nutritional advice as per their regular routine monthly door to door community services
Other Name: nutrition education

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659061

Locations
Pakistan
AKU-Peds Naushero Feroze Site Office
Naushero Feroze, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
MicroNutrient Initiative
M/S SEBCON
Pakistan Ministry of Health
National Programme of Family Planning and Primary Health Care
Investigators
Study Chair: Zulfiqar A Bhutta, MD, PhD Aga Khan University
  More Information

No publications provided

Responsible Party: Zulfiqar Ahmed Bhutta / Chair & Professor, Dept of Paediatrics and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT00659061     History of Changes
Other Study ID Numbers: 754-Ped/ERC-07
Study First Received: April 14, 2008
Results First Received: December 15, 2008
Last Updated: May 28, 2009
Health Authority: Pakistan: Ministry of Health

Keywords provided by Aga Khan University:
micronutrients

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014