Zambia Micronutrient Powder Trial Effectiveness Study

NCT01878734 | Completed

• 1 other identifier: H13-00261
• Study Type: interventional
• Target: 631
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anaemia; Stunting

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the occurrence of Iron Deficiency Anemia

  One year

Secondary Outcomes (1)

• Change from Baseline in the Occurrence of Stunting

  One year

Study Arms (2)

Control

NO INTERVENTION

This arm will act as a control and will not receive Micronutrient Powders

Micronutrient Powders

EXPERIMENTAL

This is the treatment arm, which will be receiving Micronutrient Powders (MNP)

Dietary Supplement: Micronutrient Powders

Interventions

Micronutrient Powders DIETARY_SUPPLEMENT

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.

Micronutrient Powders

Eligibility Criteria

• Age: 6 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Tropical Disease Research Centre: collaborator
• UNICEF: collaborator
• Ministry of Health, Zambia: collaborator

Study Sites (1)

Villages in the Mbala District

Mbala, Northern Province, Zambia

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Growth Disorders

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mélanie Suter

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Agnes Aongola

  Ministry of Health, Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 17, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

ZA (1)