Monitoring and Evaluation of Micronutrients (Sprinkles) Project

NCT00659061 | Completed Results

• 1 other identifier: 754-Ped/ERC-07
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

micronutrients

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Mean Hemoglobin of Participants Post Intervention

  Endline Hb taken 4-5 months post enrollment

Secondary Outcomes (5)

• Vitamin A Status of Participants - Post Intervention

  Measurement taken 4-5 months post enrollment

• Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention

  Measurement taken 4-5 months post enrollment

• Percentage of Underweight Participants

  Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment

• Percentage of Participants With Stunted Growth

  Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment

• Percentage of Participants With Wasted Growth

  Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.

Dietary Supplement: SPRINKLES; Behavioral: Nutrition education

Control

NO INTERVENTION

Routine public health massages by Lady Health Workers (LHWs) during their community visits.

Interventions

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.

Also known as: Multiple micronutrient fortificant

Intervention

Nutrition education BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• Micronutrient Initiative: collaborator
• M/S SEBCON: collaborator
• Pakistan Ministry of Health: collaborator
• National Programme of Family Planning and Primary Health Care: collaborator

Study Sites (1)

AKU-Peds Naushero Feroze Site Office

Naushero Feroze, Sindh, Pakistan

Location

MeSH Terms

Conditions

Anemia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Limitations and Caveats

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

• Title: Professor Zulfiqar Ahmed Bhutta
• Organization: Aga Khan University

zulfiqar.bhutta@aku.edu

4930051

Study Officials

• Zulfiqar A Bhutta, MD, PhD

  Aga Khan University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founding Director, Centre of Excellence in Women and Child Health

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 16, 2008
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: February 1, 2018
• Results First Posted: May 27, 2009

Record last verified: 2018-01

Locations

PA (1)