AnemiaNCT00210405
Feasibility and Effectiveness of Distributing Micronutrient Sprinkles to Reduce Prevalence of Anemia
A study testing "Sprinkles" containing mulitple micronutrients, Education/communication on use of micronutrient sprinkles and Fortified food aid (corn-soy blend) in people with Anemia, run by International Food Policy Research Institute at 1 site in Haiti.
Trial summary
The objective of this study is to test the feasibility and effectiveness of distributing micronutrient sprinkles to 6-20 month old children participating in an integrated maternal and child health and nutrition program in rural Haiti. Read more about this study
- Who is it for?
- Ages 6 to 20 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- "Sprinkles" containing mulitple micronutrients, Education/communication on use of micronutrient sprinkles and Fortified food aid (corn-soy blend)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteHaiti
- Study dates
- Mar 2005to Sep 2005
- Phase
- Interventional
- 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 to 20 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-20 months old at time of recruitment
- Family receives food rations at World Vision-Haiti's Food Distribution Points
Who cannot join
- Severe anemia at time of recruitment (hemoglobin <7.0 g/dl)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Feasibility and Effectiveness of Distributing Micronutrient Sprinkles Within a Title II Food Aid and Maternal and Child Health Program in Rural Haiti
The objective of this study is to test the feasibility and effectiveness of distributing micronutrient sprinkles to 6-20 month old children participating in an integrated maternal and child health and nutrition program in rural Haiti. The micronutrient sprinkles have been formulated to prevent or treat anemia in 6-23 month old children. Effectiveness in reducing the prevalence of anemia will be assessed.
Read the detailed description
Anemia is highly prevalent among infants and young children in Haiti and throughout the world. Low intakes of several micronutrients contribute to this problem. It is very difficult to meet the micronutrient needs of infants and young children without substantial amounts of animal-source foods; such foods are not affordable for most families in many poor communities.
Micronutrient sprinkles are a novel approach to meeting children's needs. The sprinkles are packed in sachets containing a daily ration, and are intended to be used in the home and "sprinkled" directly on the children's food. Earlier trials have shown the efficacy of the sprinkles for preventing and treating anemia under controlled conditions.
The current study tests the feasibility and effectiveness when sprinkles are distributed in the programmatic context of a US Title II food aid distribution program, a context that is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study also includes the development and dissemination of educational messages to motivate and enable caregivers to use the sprinkles properly. Based on previous efficacy trials no side-effects are anticipated, but the study also monitors for unanticipated side-effects.
Comparison: Since effectiveness of the sprinkles distributed as part of a take-home ration has not been established, this study employed a randomized controlled design. Randomization occurred at the level of the food distribution point (place where community members gather to receive food rations). Groups were assigned to receive either the take home ration (usual program practice) or the take home ration and the sprinkles. Families receiving only food rations at the control sites will receive sprinkles along with their food ration immediately after data collection is complete. The design was also consistent with the program necessity of a gradual roll-out of this new intervention. The prevalence of anemia among target-age children will be compared between groups that receive a two-month supply of micronutrient sprinkles with their take-home food ration, and those that do not.
- Conditions
- Anemia
- Being tested
- "Sprinkles" containing mulitple micronutrients, Education/communication on use of micronutrient sprinkles, Fortified food aid (corn-soy blend)
- Keywords
- Anemia, Infant nutrition, Dietary supplements, Randomized controlled trials, Evaluation studies, Haiti
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Sprinkles" containing mulitple micronutrientsDietary supplement
Education/communication on use of micronutrient sprinklesBehavioural
Fortified food aid (corn-soy blend)Dietary supplement
This intervention was part of the overall food assisted maternal and child health and nutrition program, and included fortified food aid commodities. Corn soy blend was targeted to the child, while the family also received wheat, lentils and oil.
| Study group | Role | What they receive |
|---|---|---|
| Food aid only | Active comparator | Children in this arm received fortified food aid commodities supplied through the maternal and child health and nutrition program implemented by World Vision. They received fortified corn-soy blend, which contained iron. Receives: Dietary Supplement: Fortified food aid (corn-soy blend) |
| Micronutrient sprinkles + food aid | Experimental | Children in this arm were enrolled in the food assisted program, and therefore received fortified food aid, as well as 60 sachets of a multiple micronutrient powder (Sprinkles) containing iron, zinc, vitamin A, vitamin C and folic acid Receives: Dietary Supplement: "Sprinkles" containing mulitple micronutrients; Behavioral: Education/communication on use of micronutrient sprinkles; Dietary Supplement: Fortified food aid (corn-soy blend) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anemia after 2 months of treatment
Secondary outcomes (1)
Prevalence of symptoms of morbidity at 1 and 2 months after treatment begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, World Vision, Micronutrient Initiative
- Investigators
- Marie T. Ruel, PhD, Principal investigator, International Food Policy Research InstitutePurnima Menon, PhD, Principal investigator, International Food Policy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210405
- Sponsor's protocol ID
- 10-0460-INTFOO-01-3-IFPRI
- Status last verified
- Aug 2012
- First submitted
- 13 Sep 2005
- Last updated
- 30 Aug 2012
- Results posted
- No
Publications
Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.
PubMed 15646314Zlotkin S, Arthur P, Schauer C, Antwi KY, Yeung G, Piekarz A. Home-fortification with iron and zinc sprinkles or iron sprinkles alone successfully treats anemia in infants and young children. J Nutr. 2003 Apr;133(4):1075-80. doi: 10.1093/jn/133.4.1075.
PubMed 12672922Menon P, Ruel MT, Loechl CU, Arimond M, Habicht JP, Pelto G, Michaud L. Micronutrient Sprinkles reduce anemia among 9- to 24-mo-old children when delivered through an integrated health and nutrition program in rural Haiti. J Nutr. 2007 Apr;137(4):1023-30. doi: 10.1093/jn/137.4.1023.
PubMed 17374671Loechl CU, Menon P, Arimond M, Ruel MT, Pelto G, Habicht JP, Michaud L. Using programme theory to assess the feasibility of delivering micronutrient Sprinkles through a food-assisted maternal and child health and nutrition programme in rural Haiti. Matern Child Nutr. 2009 Jan;5(1):33-48. doi: 10.1111/j.1740-8709.2008.00154.x.
PubMed 19161543
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Effectiveness of Distributing Micronutrient Sprinkles Within a Title II Food Aid and Maternal and Child Health Program in Rural Haiti
- ClinicalTrials.gov ID
- NCT00210405
- Acronym / sponsor ID
- 10-0460-INTFOO-01-3-IFPRI
- Conditions
- Anemia
- Keywords
- Anemia, Infant nutrition, Dietary supplements, Randomized controlled trials, Evaluation studies, Haiti
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Cornell University, World Vision, Micronutrient Initiative
- Study start
- Mar 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 21 Sep 2005 (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 objective of this study is to test the feasibility and effectiveness of distributing micronutrient sprinkles to 6-20 month old children participating in an integrated maternal and child health and nutrition program in rural Haiti. The micronutrient sprinkles have been formulated to prevent or treat anemia in 6-23 month old children. Effectiveness in reducing the prevalence of anemia will be assessed.
Detailed description
Anemia is highly prevalent among infants and young children in Haiti and throughout the world. Low intakes of several micronutrients contribute to this problem. It is very difficult to meet the micronutrient needs of infants and young children without substantial amounts of animal-source foods; such foods are not affordable for most families in many poor communities.
Micronutrient sprinkles are a novel approach to meeting children's needs. The sprinkles are packed in sachets containing a daily ration, and are intended to be used in the home and "sprinkled" directly on the children's food. Earlier trials have shown the efficacy of the sprinkles for preventing and treating anemia under controlled conditions.
The current study tests the feasibility and effectiveness when sprinkles are distributed in the programmatic context of a US Title II food aid distribution program, a context that is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study also includes the development and dissemination of educational messages to motivate and enable caregivers to use the sprinkles properly. Based on previous efficacy trials no side-effects are anticipated, but the study also monitors for unanticipated side-effects.
Comparison: Since effectiveness of the sprinkles distributed as part of a take-home ration has not been established, this study employed a randomized controlled design. Randomization occurred at the level of the food distribution point (place where community members gather to receive food rations). Groups were assigned to receive either the take home ration (usual program practice) or the take home ration and the sprinkles. Families receiving only food rations at the control sites will receive sprinkles along with their food ration immediately after data collection is complete. The design was also consistent with the program necessity of a gradual roll-out of this new intervention. The prevalence of anemia among target-age children will be compared between groups that receive a two-month supply of micronutrient sprinkles with their take-home food ration, and those that do not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food aid only | Active comparator | Dietary Supplement: Fortified food aid (corn-soy blend)Children in this arm received fortified food aid commodities supplied through the maternal and child health and nutrition program implemented by World Vision. They received fortified corn-soy blend, which contained iron. |
| Micronutrient sprinkles + food aid | Experimental | Dietary Supplement: "Sprinkles" containing mulitple micronutrients, Behavioral: Education/communication on use of micronutrient sprinkles, Dietary Supplement: Fortified food aid (corn-soy blend)Children in this arm were enrolled in the food assisted program, and therefore received fortified food aid, as well as 60 sachets of a multiple micronutrient powder (Sprinkles) containing iron, zinc, vitamin A, vitamin C and folic acid |
Who may qualify
- Ages
- 6 to 20 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6-20 months old at time of recruitment
- Family receives food rations at World Vision-Haiti's Food Distribution Points
Key exclusion criteria (1 listed)
- Severe anemia at time of recruitment (hemoglobin <7.0 g/dl)
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 |
|---|---|---|
| "Sprinkles" containing mulitple micronutrients | Dietary supplement | Micronutrient sprinkles + food aid |
| Education/communication on use of micronutrient sprinkles | Behavioural | Micronutrient sprinkles + food aid |
| Fortified food aid (corn-soy blend)This intervention was part of the overall food assisted maternal and child health and nutrition program, and included fortified food aid commodities. Corn soy blend was targeted to the child, while the family also received wheat, lentils and oil. | Dietary supplement | Food aid only, Micronutrient sprinkles + food aid |
Primary outcome
Prevalence of anemia after 2 months of treatment
1 secondary outcome
Prevalence of symptoms of morbidity at 1 and 2 months after treatment begins
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 Aug 2012.
- Background: PubMed 15646314Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.
- Background: PubMed 12672922Zlotkin S, Arthur P, Schauer C, Antwi KY, Yeung G, Piekarz A. Home-fortification with iron and zinc sprinkles or iron sprinkles alone successfully treats anemia in infants and young children. J Nutr. 2003 Apr;133(4):1075-80. doi: 10.1093/jn/133.4.1075.
- Results publication: PubMed 17374671Menon P, Ruel MT, Loechl CU, Arimond M, Habicht JP, Pelto G, Michaud L. Micronutrient Sprinkles reduce anemia among 9- to 24-mo-old children when delivered through an integrated health and nutrition program in rural Haiti. J Nutr. 2007 Apr;137(4):1023-30. doi: 10.1093/jn/137.4.1023.
- Results publication: PubMed 19161543Loechl CU, Menon P, Arimond M, Ruel MT, Pelto G, Habicht JP, Michaud L. Using programme theory to assess the feasibility of delivering micronutrient Sprinkles through a food-assisted maternal and child health and nutrition programme in rural Haiti. Matern Child Nutr. 2009 Jan;5(1):33-48. doi: 10.1111/j.1740-8709.2008.00154.x.
- Sprinkles Global Health InitiativeLink 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.
Marie T. Ruel, PhD principal investigator
International Food Policy Research Institute
Purnima Menon, PhD principal investigator
International Food Policy Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Sprinkles" containing mulitple micronutrients, Education/communication on use of micronutrient sprinkles and Fortified food aid (corn-soy blend) in people with Anemia, run by International Food Policy Research Institute at 1 site in Haiti.
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 1 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 Aug 2012. 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 Haiti. 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.
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?
Prevalence of anemia after 2 months of treatment. 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 NCT00210405, which also lists 4 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 Aug 2012.