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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
History of Changes
Results First Received: December 15, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Anemia
Interventions: Dietary Supplement: SPRINKLES
Behavioral: Advice only

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Sprinkle-Advice     Advice Only  
STARTED     308     302  
COMPLETED     287 [1]   287 [1]
NOT COMPLETED     21     15  
Migration due to political unrest                 21                 15  
[1] Those with either complete or partial biochemical and anthropometric data



  Baseline Characteristics
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Sprinkle-Advice     Advice Only     Total  
Number of Participants  
[units: participants]
 		  308     302     610  
Age  
[units: months]
Mean ± Standard Deviation 		  12  ± 3.2     12.3  ± 3.3     12.2  ± 3.3  
Gender  
[units: participants]
 		     
Female     172     155     327  
Male     136     147     283  



  Outcome Measures
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1.  Primary:   Number of Participants With Anemia   [ Time Frame: Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment ]
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2.  Primary:   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 ]
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3.  Primary:   Mean Hemoglobin of Participants Post Intervention   [ Time Frame: Endline Hb taken 4-5 months post enrollment ]
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4.  Secondary:   Vitamin A Status of Participants - Post Intervention   [ Time Frame: Measurement taken 4-5 months post enrollment ]
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5.  Secondary:   Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention   [ Time Frame: Measurement taken 4-5 months post enrollment ]
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6.  Secondary:   Percentage of Underweight Participants   [ Time Frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment ]
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7.  Secondary:   Percentage of Participants With Stunted Growth   [ Time Frame: Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment ]
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8.  Secondary:   Percentage of Participants With Wasted Growth   [ Time Frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Professor Zulfiqar Ahmed Bhutta
Organization: Aga Khan University
phone: 4930051 ext 4782
e-mail: zulfiqar.bhutta@aku.edu


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