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Monitoring and Evaluation of Micronutrients (Sprinkles) Project (Sprinkles)

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ClinicalTrials.gov Identifier: NCT00659061
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : May 27, 2009
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
Micronutrient Initiative
M/S SEBCON
Pakistan Ministry of Health
National Programme of Family Planning and Primary Health Care
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Anemia Dietary Supplement: SPRINKLES Behavioral: Nutrition education Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 610 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Monitoring and Evaluation of Micronutrients (Sprinkles) Project
Study Start Date : August 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Intervention
Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.
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: Nutrition education
Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
No Intervention: Control
Routine public health massages by Lady Health Workers (LHWs) during their community visits.



Primary Outcome Measures :
  1. 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)

  2. 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

  3. Mean Hemoglobin of Participants Post Intervention [ Time Frame: Endline Hb taken 4-5 months post enrollment ]

Secondary Outcome Measures :
  1. Vitamin A Status of Participants - Post Intervention [ Time Frame: Measurement taken 4-5 months post enrollment ]
    Categorized as <20ug/dL; 20-40 ug/dL; >40 ug/dl

  2. Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention [ Time Frame: Measurement taken 4-5 months post enrollment ]
  3. Percentage of Underweight Participants [ Time Frame: 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)

  4. Percentage of Participants With Stunted Growth [ Time Frame: 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

  5. Percentage of Participants With Wasted Growth [ Time Frame: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment ]
    Wasted defined as Weight for Height Z-score < -2SD



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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Zulfiqar Ahmed Bhutta, Founding Director, Centre of Excellence in Women and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT00659061     History of Changes
Other Study ID Numbers: 754-Ped/ERC-07
First Posted: April 16, 2008    Key Record Dates
Results First Posted: May 27, 2009
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:
micronutrients

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs