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Completed

NCT Number: NCT00659061

Monitoring and Evaluation of Micronutrients (Sprinkles) Project

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AKU-Peds Naushero Feroze Site Office

Naushero Feroze, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPRINKLES

Dietary Supplement

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 names: Multiple micronutrient fortificant

Nutrition Education

Behavioral

Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • M/S SEBCON
  • Micronutrient Initiative
  • National Programme of Family Planning and Primary Health Care
  • Pakistan Ministry of Health

Registry information

Acronym: Sprinkles

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 16, 2008
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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