Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya

NCT01088958 | Completed Phase 4

• 1 other identifier: CDC-NCEZID-5039
• Study Type: interventional
• Target: 7,200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the effectiveness of household-based distribution of evidence-based health products and to measure the health impact of these combined interventions on a population basis.

Conditions

Anemia, Iron-deficiency

Keywords

Kenya; Child Nutrition Disorders; Social marketing

Outcome Measures

Primary Outcomes (1)

• Product sales and use (coverage)

  Biweekly household visits of selected cohort take place to assess purchases and use of health products and self reported morbidity outcomes. Household visits started at enrollment and continued throughout 2-year study period.

  Every 2 weeks

Secondary Outcomes (2)

• Prevalence of anemia

  Baseline and 12 and 24-month follow-up surveys

• Prevalence of iron deficiency

  Baseline and 12 and 24-month follow-up surveys

Study Arms (1)

Micronutrient Sprinkles

EXPERIMENTAL

Sales of Sprinkles in these groups of villages by community vendors

Dietary Supplement: Micronutrient powders (Sprinkles)

Interventions

Micronutrient powders (Sprinkles) DIETARY_SUPPLEMENT

Sprinkles were developed in 1996 by Stanley Zlotkin's research group at the Hospital for Sick Children, University of Toronto as a novel approach for delivering iron and other micronutrients. They come in 1g sachets of dry powder that is then added to any home-prepared semi-solid food, intended for daily consumption by children aged 6-59 months. Formulation includes: Iron (Ferrous fumarate) 12.5 mg, Folic acid 150 µg, Vitamin A 375 µg, Vitamin C 35 mg, Zinc 5 mg, Vitamin B1 0.5 mg, Vitamin B2 0.5 mg, Vitamin B6 0.5 mg, Vitamin B12 0.9 µg, Vitamin D3 5 µg, Vitamin E 6.0 mg, Niacin 6.0 mg, Copper 0.6 mg, Iodine 50 µg

Micronutrient Sprinkles

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-36 months at the time of enrollment
• Live within the study area for the duration of the intervention and follow-up period

You may not qualify if:

• Unavailable for enrollment on 3 separate household visits
• Parental refusal to give informed consent

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Safe Water and AIDS Project: collaborator
• Kenya Medical Research Institute: collaborator
• Global Alliance for Improved Nutrition: collaborator

Study Sites (1)

CDC/Kenya Medical Research Institute

Kisumu, Kenya

Location

Related Publications (7)

• Centers for Disease Control and Prevention (CDC). Baseline data from the Nyando Integrated Child Health and Education Project--Kenya, 2007. MMWR Morb Mortal Wkly Rep. 2007 Oct 26;56(42):1109-13.

  PMID: 17962803 RESULT

• Suchdev PS, Leeds IL, McFarland DA, Flores R. Is it time to change guidelines for iron supplementation in malarial areas? J Nutr. 2010 Apr;140(4):875-6. doi: 10.3945/jn.109.118638. Epub 2010 Feb 10. No abstract available.

  PMID: 20147465 RESULT

• Suchdev PS, Ruth L, Obure A, Were V, Ochieng C, Ogange L, Owuor M, Ngure F, Quick R, Juliao P, Jung C, Teates K, Cruz K, Jefferds ME. Monitoring the marketing, distribution, and use of Sprinkles micronutrient powders in rural western Kenya. Food Nutr Bull. 2010 Jun;31(2 Suppl):S168-78. doi: 10.1177/15648265100312S209.

  PMID: 20715601 RESULT

• Davis JN, Williams A, Arnold CD, Rohner F, Wirth JP, Addo Y, Flores-Ayala RC, Oaks BM, Young MF, Suchdev PS, Engle-Stone R. The Relationship Between Ferritin and BMI is Mediated by Inflammation Among Women in Higher-Income Countries, But Not in Most Lower-Income Countries Nor Among Young Children: A Multi-Country Analysis. Curr Dev Nutr. 2022 Sep 9;6(10):nzac139. doi: 10.1093/cdn/nzac139. eCollection 2022 Oct.

  PMID: 36475018 DERIVED

• Suchdev PS, Addo OY, Martorell R, Grant FK, Ruth LJ, Patel MK, Juliao PC, Quick R, Flores-Ayala R. Effects of community-based sales of micronutrient powders on morbidity episodes in preschool children in Western Kenya. Am J Clin Nutr. 2016 Mar;103(3):934-41. doi: 10.3945/ajcn.115.118000. Epub 2016 Feb 10.

  PMID: 26864367 DERIVED

• Suchdev PS, Ruth LJ, Woodruff BA, Mbakaya C, Mandava U, Flores-Ayala R, Jefferds ME, Quick R. Selling Sprinkles micronutrient powder reduces anemia, iron deficiency, and vitamin A deficiency in young children in Western Kenya: a cluster-randomized controlled trial. Am J Clin Nutr. 2012 May;95(5):1223-30. doi: 10.3945/ajcn.111.030072. Epub 2012 Apr 4.

  PMID: 22492366 DERIVED

• Grant FK, Martorell R, Flores-Ayala R, Cole CR, Ruth LJ, Ramakrishnan U, Suchdev PS. Comparison of indicators of iron deficiency in Kenyan children. Am J Clin Nutr. 2012 May;95(5):1231-7. doi: 10.3945/ajcn.111.029900. Epub 2012 Mar 28.

  PMID: 22456661 DERIVED

Related Links

• Implementing NGO

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders

Study Officials

• Parminder S Suchdev, MD MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 18, 2010
• Study Start: January 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: September 1, 2014
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

KE (1)