Zambia Micronutrient Powder Trial Effectiveness Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01878734
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : June 4, 2015
Tropical Disease Research Centre
Ministry of Health, Zambia
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Iron Deficiency Anaemia Stunting Dietary Supplement: Micronutrient Powders Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 631 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change from Baseline in the occurrence of Iron Deficiency Anemia [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Change from Baseline in the Occurrence of Stunting [ Time Frame: One year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   6 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01878734

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

Responsible Party: University of British Columbia Identifier: NCT01878734     History of Changes
Other Study ID Numbers: H13-00261
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

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