AnemiaNCT00392418
Flexible Administration of Sprinkles® in Infants and Young Children in Rural Bangladesh.
A study testing Multiple micronutrient supplement (iron) in people with Anemia, run by The Hospital for Sick Children at 1 site in Bangladesh.
Trial summary
Millions of people worldwide are affected by iron deficiency anemia (IDA). IDA is a widespread serious public health problem, especially for infants in developing countries mainly because of inadequate intake of iron due to the poor bioavailability of dietary iron in predominately cereal based diets. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Anemia
- What is being tested?
- Multiple micronutrient supplement (iron)
- How many people
- 360 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2004to Mar 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 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-24 months.
- Hemoglobin concentration > =70 g/L.
- Consuming at least one regular meal of complementary food per day.
- Reportedly free from any acute or chronic illness.
- Permanent resident of the village.
- Not receiving any other form of iron supplementation.
- Parental consent obtained.
Who cannot join
- Severe anemia (hemoglobin concentration <70 g/L).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Flexible Administration of Sprinkles® in a Mixed Population of Anemic and Non-anemic Infants and Young Children in Rural Bangladesh.
Millions of people worldwide are affected by iron deficiency anemia (IDA). IDA is a widespread serious public health problem, especially for infants in developing countries mainly because of inadequate intake of iron due to the poor bioavailability of dietary iron in predominately cereal based diets. One of the ways to combat iron deficiency anemia is by supplementation to targeted populations. Although iron drops have been used, they have been largely unsuccessful in reducing the prevalence of anemia because of compliance, distribution and supply issues. Sprinkles® are a new approach to iron delivery that is as efficacious as iron drops and more acceptable. For Sprinkles® to be implemented into nation-wide programs as a sustainable alternative to current iron supplementation approaches, an optimal model of use and distribution for Sprinkles® needs to be established. By comparing daily versus flexible use of Sprinkles® (60 sachets over 60, 90 and 120 days) among infants and young children aged 6-24 months, the primary objectives are to study the effect of the three administration models of Sprinkles® on changes in:
- hemoglobin concentration; and
- compliance or adherence to the intervention. ii. The secondary objective of this study is to determine the acceptability of each of the three intervention models.
We hypothesize that adherence will be greater and hemoglobin concentration response will be higher in those given 'flexible' instructions to use all of the Sprinkles® supplied over a specific period of time compared to those given strict instructions for daily use.
Read the detailed description
Study Design
This study will follow a community-based cluster randomized clinical trial design involving three intervention groups. Total number of villages included in the study will be determined by the availability of the eligible children. In each village, all eligible children will be screened through house-to-house visits. After the screening, all the children will be randomized by village using a table with randomly assorted table into one of three groups:
- Daily use of 60 Sprinkles® sachets over 60 days.
- Flexible use of 60 Sprinkles® sachets over 90 days.
- Flexible use of 60 Sprinkles® sachets over 120 days.
In all groups, assessments will be done at baseline, at the end of a group's intervention and at 6 months after intervention in each group for follow-up.
The study will take place in Kaligong sub-district in Bangladesh. All villages in Kaligonj sub-district consist of plain agricultural land. Subsistence farming is the major source of livelihood. Rice is the commonly eaten staple mixed with lentil and vegetable curry and occasionally with pieces of fish and meat. Similar to the rest of the plain areas of the country, malnutrition among women and children is widespread, but malaria is extremely uncommon and the prevalence of hookworm is fairly low (less than 2%%).
- Conditions
- Anemia
- Being tested
- Multiple micronutrient supplement (iron)
- Keywords
- iron deficiency anemia, hematologic disease, infancy, pediatrics, Sprinkles®, iron, micronutrient
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrient supplement (iron)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin concentration
Measured: at end of treatment and 6 months post-treatment
adherence measured by the number of sachets used
Measured: end of treatment
Secondary outcomes (4)
Acceptability measured through interview with mothers
weaning food practice at treatment end and 6 months post-treatment
length and weight at treatment end and 6 months post-treatment
morbidity from diarrhea and acute respiratory infections at treatment end and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startMay 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Single blind
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Heinz Endowments
- Responsible party
- Principal investigator, Stanley Zlotkin, The Hospital for Sick Children
- Investigators
- Stanley H Zlotkin, PhD, Principal investigator, The Hospital for Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392418
- Sponsor's protocol ID
- 1000005427
- Status last verified
- Apr 2021
- First submitted
- 24 Oct 2006
- Last updated
- 19 Apr 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Flexible Administration of Sprinkles® in a Mixed Population of Anemic and Non-anemic Infants and Young Children in Rural Bangladesh.
- ClinicalTrials.gov ID
- NCT00392418
- Acronym / sponsor ID
- 1000005427
- Conditions
- Anemia
- Keywords
- iron deficiency anemia, hematologic disease, infancy, pediatrics, Sprinkles®, iron, micronutrient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Heinz Endowments
- Study start
- May 2004
- Study completion
- Mar 2005
- First posted
- 26 Oct 2006 (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.
Millions of people worldwide are affected by iron deficiency anemia (IDA). IDA is a widespread serious public health problem, especially for infants in developing countries mainly because of inadequate intake of iron due to the poor bioavailability of dietary iron in predominately cereal based diets. One of the ways to combat iron deficiency anemia is by supplementation to targeted populations. Although iron drops have been used, they have been largely unsuccessful in reducing the prevalence of anemia because of compliance, distribution and supply issues. Sprinkles® are a new approach to iron delivery that is as efficacious as iron drops and more acceptable. For Sprinkles® to be implemented into nation-wide programs as a sustainable alternative to current iron supplementation approaches, an optimal model of use and distribution for Sprinkles® needs to be established. By comparing daily versus flexible use of Sprinkles® (60 sachets over 60, 90 and 120 days) among infants and young children aged 6-24 months, the primary objectives are to study the effect of the three administration models of Sprinkles® on changes in:
- hemoglobin concentration; and
- compliance or adherence to the intervention. ii. The secondary objective of this study is to determine the acceptability of each of the three intervention models.
We hypothesize that adherence will be greater and hemoglobin concentration response will be higher in those given 'flexible' instructions to use all of the Sprinkles® supplied over a specific period of time compared to those given strict instructions for daily use.
Detailed description
Study Design
This study will follow a community-based cluster randomized clinical trial design involving three intervention groups. Total number of villages included in the study will be determined by the availability of the eligible children. In each village, all eligible children will be screened through house-to-house visits. After the screening, all the children will be randomized by village using a table with randomly assorted table into one of three groups:
- Daily use of 60 Sprinkles® sachets over 60 days.
- Flexible use of 60 Sprinkles® sachets over 90 days.
- Flexible use of 60 Sprinkles® sachets over 120 days.
In all groups, assessments will be done at baseline, at the end of a group's intervention and at 6 months after intervention in each group for follow-up.
The study will take place in Kaligong sub-district in Bangladesh. All villages in Kaligonj sub-district consist of plain agricultural land. Subsistence farming is the major source of livelihood. Rice is the commonly eaten staple mixed with lentil and vegetable curry and occasionally with pieces of fish and meat. Similar to the rest of the plain areas of the country, malnutrition among women and children is widespread, but malaria is extremely uncommon and the prevalence of hookworm is fairly low (less than 2%%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 6-24 months.
- Hemoglobin concentration > =70 g/L.
- Consuming at least one regular meal of complementary food per day.
- Reportedly free from any acute or chronic illness.
- Permanent resident of the village.
Key exclusion criteria (1 listed)
- Severe anemia (hemoglobin concentration <70 g/L).
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 |
|---|---|---|
| Multiple micronutrient supplement (iron) | Drug | – |
Primary outcome
hemoglobin concentration
Time frame: at end of treatment and 6 months post-treatment
adherence measured by the number of sachets used
Time frame: end of treatment
4 secondary outcomes
Acceptability measured through interview with mothers
weaning food practice at treatment end and 6 months post-treatment
length and weight at treatment end and 6 months post-treatment
morbidity from diarrhea and acute respiratory infections at treatment end and 6 months post treatment
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 19 Apr 2021.
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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.
Stanley H Zlotkin, PhD principal investigator
The Hospital for Sick Children, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple micronutrient supplement (iron) in people with Anemia, run by The Hospital for Sick Children at 1 site in Bangladesh.
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 7 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 19 Apr 2021. 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 Bangladesh. 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?
hemoglobin concentration (time frame: at end of treatment and 6 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.