Monitoring and Evaluation of Micronutrients (Sprinkles) Project

Anemia Clinical Trial

— Sprinkles  

Official title:

Monitoring and Evaluation of Micronutrients (Sprinkles) Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659061
• Other study ID #: 754-Ped/ERC-07
• Status: Completed
• Phase: N/A
• First received: April 14, 2008
• Last updated: January 8, 2018
• Start date: August 2007
• Est. completion date: May 2008

Study information

• Verified date: January 2018
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

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.

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

Locations

Country	Name	City	State
Pakistan	AKU-Peds Naushero Feroze Site Office	Naushero Feroze	Sindh

Sponsors (5)

Lead Sponsor	Collaborator
Aga Khan University	M/S SEBCON, Micronutrient Initiative, National Programme of Family Planning and Primary Health Care, Pakistan Ministry of Health

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Anemia	number with mild to severe anemia (hemoglobin(Hb)<11g/dL)	Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
Primary	Number of Participants With Moderate to Severe Anemia	number of participants with moderate - severe anemia defined as Hb < 10g/dL	Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment
Primary	Mean Hemoglobin of Participants Post Intervention		Endline Hb taken 4-5 months post enrollment
Secondary	Vitamin A Status of Participants - Post Intervention	Categorized as <20ug/dL; 20-40 ug/dL; >40 ug/dl	Measurement taken 4-5 months post enrollment
Secondary	Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention		Measurement taken 4-5 months post enrollment
Secondary	Percentage of Underweight Participants	Underweight defined as Weight for Age Z score < -2 standard deviation (SD)	Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment
Secondary	Percentage of Participants With Stunted Growth	Stunted defined as Height for Age Z-score < -2 standard deviation	Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment
Secondary	Percentage of Participants With Wasted Growth	Wasted defined as Weight for Height Z-score < -2SD	Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment