Anemia, Iron-deficiencyPhase 4NICHENCT01088958
Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya
A Phase 4 study testing Micronutrient powders (Sprinkles) in people with Anemia, Iron-deficiency, run by Centers for Disease Control and Prevention at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-deficiency
- What is being tested?
- Micronutrient powders (Sprinkles)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2007to Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-36 months at the time of enrollment
- Live within the study area for the duration of the intervention and follow-up period
Who cannot join
- Unavailable for enrollment on 3 separate household visits
- Parental refusal to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diarrhea, Malaria, Anemia, and Helminthiasis Prevention Through Household-based Interventions in Rural Western Kenya: the Nyando Integrated Child Health and Education (NICHE) Project
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.
Read the detailed description
Nyanza Province has the highest mortality rates for infants and children under 5 years of age and the highest HIV prevalence rates in Kenya. Burden of disease in western Kenya is further characterized by endemic malaria transmission, diarrheal diseases due to poor access to safe water, and iron deficiency anemia (IDA) in over 60% of children. Access to health interventions in rural Nyanza Province is poor due to limited transportation and communication infrastructure. Delivery of household-based interventions through local institutions offers the potential for increased utilization and improved health outcomes in rural areas. The Centers for Disease Control and Prevention (CDC) in partnership with the Rotary-supported Safe Water and AIDS Project (SWAP), initiated a program in 2007 that combines household, clinic, school, and local commercial distribution approaches to increase access to various evidence-based health products (WaterGuard(TM) and PuR(TM) water disinfectant products, water storage containers, soap, insecticide treated bednets, micronutrient Sprinkles(TM), and albendazole) and measures the health impact of these combined interventions on a population basis.
Evaluation of the intervention will take place over 36 months and will include: 1) baseline and follow-up cross sectional surveys among households in communities visited by SWAP for purchase of products; 2) active household surveillance of diarrhea, febrile illness and Sprinkles(TM) usage; 3) testing of hemoglobin and iron status and anthropometry measurement among children aged 6-35 months; 4) focus groups and targeted interviews to assess the acceptability of health products; and 5) other program evaluation methods.
During the baseline and follow-up surveys, demographic information, water, sanitation, hygiene, and health information, dietary intake history, and other data will be collected by questionnaire. A blood specimen collected by fingerstick will be used to test for hemoglobin concentration, malaria parasitemia, and iron status. Follow-up surveys 12 and 24 months after baseline data collection will include collection of similar data to assess the effectiveness of product distribution. Anthropometry will be measured at baseline, 12, and 24 months. Qualitative information on user preferences will be obtained using ongoing focus groups, observations and targeted interviews. The results of these evaluations will be published in reports distributed to SWAP, the Kenyan government, and local NGO's and in peer-reviewed journals.
- Conditions
- Anemia, Iron-deficiency
- Being tested
- Micronutrient powders (Sprinkles)
- Keywords
- Kenya, Child Nutrition Disorders, Social marketing
- Medical subject headings
- Anemia, Iron-Deficiency, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Micronutrient Sprinkles | Experimental | Sales of Sprinkles in these groups of villages by community vendors Receives: Dietary Supplement: Micronutrient powders (Sprinkles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 2 weeks
Secondary outcomes (2)
Prevalence of anemia
Measured: Baseline and 12 and 24-month follow-up surveys
Prevalence of iron deficiency
Measured: Baseline and 12 and 24-month follow-up surveys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startJan 2007
- Primary completionJan 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Safe Water and AIDS Project, Kenya Medical Research Institute, Global Alliance for Improved Nutrition
- Responsible party
- Sponsor
- Investigators
- Parminder S Suchdev, MD MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088958
- Sponsor's protocol ID
- CDC-NCEZID-5039
- Acronym
- NICHE
- Status last verified
- Jul 2015
- First submitted
- 26 Feb 2010
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17962803Suchdev 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.
PubMed 20147465Suchdev 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.
PubMed 20715601Davis 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.
PubMed 36475018Suchdev 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.
PubMed 26864367Suchdev 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.
PubMed 22492366Grant 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.
PubMed 22456661
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diarrhea, Malaria, Anemia, and Helminthiasis Prevention Through Household-based Interventions in Rural Western Kenya: the Nyando Integrated Child Health and Education (NICHE) Project
- ClinicalTrials.gov ID
- NCT01088958
- Acronym / sponsor ID
- NICHE / CDC-NCEZID-5039
- Conditions
- Anemia, Iron-deficiency
- Keywords
- Kenya, Child Nutrition Disorders, Social marketing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,200 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Safe Water and AIDS Project, Kenya Medical Research Institute, Global Alliance for Improved Nutrition
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nyanza Province has the highest mortality rates for infants and children under 5 years of age and the highest HIV prevalence rates in Kenya. Burden of disease in western Kenya is further characterized by endemic malaria transmission, diarrheal diseases due to poor access to safe water, and iron deficiency anemia (IDA) in over 60% of children. Access to health interventions in rural Nyanza Province is poor due to limited transportation and communication infrastructure. Delivery of household-based interventions through local institutions offers the potential for increased utilization and improved health outcomes in rural areas. The Centers for Disease Control and Prevention (CDC) in partnership with the Rotary-supported Safe Water and AIDS Project (SWAP), initiated a program in 2007 that combines household, clinic, school, and local commercial distribution approaches to increase access to various evidence-based health products (WaterGuard(TM) and PuR(TM) water disinfectant products, water storage containers, soap, insecticide treated bednets, micronutrient Sprinkles(TM), and albendazole) and measures the health impact of these combined interventions on a population basis.
Evaluation of the intervention will take place over 36 months and will include: 1) baseline and follow-up cross sectional surveys among households in communities visited by SWAP for purchase of products; 2) active household surveillance of diarrhea, febrile illness and Sprinkles(TM) usage; 3) testing of hemoglobin and iron status and anthropometry measurement among children aged 6-35 months; 4) focus groups and targeted interviews to assess the acceptability of health products; and 5) other program evaluation methods.
During the baseline and follow-up surveys, demographic information, water, sanitation, hygiene, and health information, dietary intake history, and other data will be collected by questionnaire. A blood specimen collected by fingerstick will be used to test for hemoglobin concentration, malaria parasitemia, and iron status. Follow-up surveys 12 and 24 months after baseline data collection will include collection of similar data to assess the effectiveness of product distribution. Anthropometry will be measured at baseline, 12, and 24 months. Qualitative information on user preferences will be obtained using ongoing focus groups, observations and targeted interviews. The results of these evaluations will be published in reports distributed to SWAP, the Kenyan government, and local NGO's and in peer-reviewed journals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micronutrient Sprinkles | Experimental | Dietary Supplement: Micronutrient powders (Sprinkles)Sales of Sprinkles in these groups of villages by community vendors |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6-36 months at the time of enrollment
- Live within the study area for the duration of the intervention and follow-up period
Key exclusion criteria (2 listed)
- Unavailable for enrollment on 3 separate household visits
- Parental refusal to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronutrient powders (Sprinkles)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 | Dietary supplement | Micronutrient Sprinkles |
Primary outcome
Product sales and use (coverage)
Time frame: Every 2 weeks
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.
2 secondary outcomes
Prevalence of anemia
Time frame: Baseline and 12 and 24-month follow-up surveys
Prevalence of iron deficiency
Time frame: Baseline and 12 and 24-month follow-up surveys
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Results publication: PubMed 17962803Centers 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.
- Results publication: PubMed 20147465Suchdev 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.
- Results publication: PubMed 20715601Suchdev 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.
- Derived from this study: PubMed 36475018Davis 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.
- Derived from this study: PubMed 26864367Suchdev 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.
- Derived from this study: PubMed 22492366Suchdev 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.
- Derived from this study: PubMed 22456661Grant 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.
- Implementing NGOLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parminder S Suchdev, MD MPH principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Micronutrient powders (Sprinkles) in people with Anemia, Iron-deficiency, run by Centers for Disease Control and Prevention at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product sales and use (coverage) (time frame: Every 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01088958, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.