Zambia Micronutrient Powder Trial Effectiveness Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Tropical Disease Research Centre
UNICEF - Zambia
Ministry of Health, Zambia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01878734
First received: June 5, 2013
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

Addressing micronutrient deficiencies in Zambia is recognized as a national priority by the government due to its major contribution to morbidity and mortality among children, especially infants in their formative years. One of the most successful, cost-effective, and recommended strategy to address micronutrient malnutrition is 'in-home fortification' with micronutrient powders (Sprinkles being the most widely recognized) along with nutrition education. While this intervention has proven to be safe, effective, and efficacious in numerous other countries, a specific national protocol must be developed to maximize its effect on reducing anaemia in Zambian children. The proposed research aims to inform such protocol.


Condition Intervention
Iron Deficiency Anaemia
Stunting
Dietary Supplement: Micronutrient Powders

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: MNP Pilot Study for Development of a Micronutrient Powder Home Fortification Program to Combat Anaemia Among Children 6-23 Months in Zambia

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change from Baseline in the occurrence of Iron Deficiency Anemia [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in the Occurrence of Stunting [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 620
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
This arm will act as a control and will not receive Micronutrient Powders
Experimental: Micronutrient Powders
This is the treatment arm, which will be receiving Micronutrient Powders (MNP)
Dietary Supplement: Micronutrient Powders
Mothers will receive a one box containing 30 sachets of Micronutrient Powders (MNP) every other month. MNP will be procured offshore with support from UNICEF Supply Division in Copenhagen, which maintains a list of approved MNP suppliers and ensures compliance with standard requirements and product specifications. For this study MNP will be purchased from Piramal Healthcare Ltd, India.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 6-11
  • Residing within the project catchment area, and plan on remaining in the same household for the 12 month study duration
  • Parent/guardian willingness to give consent for the child's participation in the study

Exclusion Criteria:

  • Weight-for-height Z score <3 SD
  • Mid-upper arm circumference < 11.5 cm
  • Presence of bilateral oedema
  • Severe anaemia (Hb < 7.0 g/dl)
  • HIV positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878734

Locations
Zambia
Villages in the Mbala District
Mbala, Northern Province, Zambia
Sponsors and Collaborators
University of British Columbia
Tropical Disease Research Centre
UNICEF - Zambia
Ministry of Health, Zambia
Investigators
Principal Investigator: Mélanie Suter University of British Columbia
Principal Investigator: Agnes Aongola Ministry of Health, Zambia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01878734     History of Changes
Other Study ID Numbers: H13-00261
Study First Received: June 5, 2013
Last Updated: September 10, 2013
Health Authority: Zambia: Ministry of Health

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014