Monitoring and Evaluation of Micronutrients (Sprinkles) Project - Full Text View

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

MedlinePlus related topics:

Anemia

ChemIDplus related topics:

Folic acid Iodine Cadexomer iodine Vitamin A Retinol Vitamin D Ergocalciferol Ascorbic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment

Official Title:	Monitoring and Evaluation of Micronutrients (Sprinkles) Project

Further study details as provided by Aga Khan University:

Primary Outcome Measures:

hemoglobin level [ Time Frame: baseline, endline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

urinary iodine level [ Time Frame: baseline, endline ] [ Designated as safety issue: No ]
serum ferritin [ Time Frame: baseline, endline ] [ Designated as safety issue: No ]
serum retinol [ Time Frame: baseline, endline ] [ Designated as safety issue: No ]
anthropometric measures: stunting, wasting, underweight [ Time Frame: baseline, endline ] [ Designated as safety issue: No ]

Estimated Enrollment:	612
Study Start Date:	August 2007
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sprinkle-Advice: Active Comparator 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 The intervention "Sprinkles", is packed in 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: 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
Advice only: No Intervention 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

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 FP/PHC (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 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

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

Locations


Pakistan, Sindh
	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

The National Programme of Family Planning and Primary Health Care(Lady Health Worker Programme)

Investigators


Study Chair:	Zulfiqar A Bhutta, MD, PhD	Aga Khan University

More Information

Responsible Party:	Dept of Paediatrics and Child Health, Aga Khan University ( Zulfiqar Ahmed Bhutta / Chair & Professor )
Study ID Numbers:	754-Ped/ERC-07
First Received:	April 14, 2008
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00659061
Health Authority:	Pakistan: Ministry of Health

Keywords provided by Aga Khan University:

micronutrients

Study placed in the following topic categories:

Folic Acid

Vitamin D

Retinol palmitate

Vitamin A

Zinc

Ergocalciferols

Anemia

Iodine

Iron

Ascorbic Acid

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Aga Khan University Micronutrient Initiative M/S SEBCON Pakistan Ministry of Health The National Programme of Family Planning and Primary Health Care(Lady Health Worker Programme)
Information provided by:	Aga Khan University
ClinicalTrials.gov Identifier:	NCT00659061