AnemiaNCT00213161
Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India
A study testing iron supplement, iron drops in people with Anemia, run by The Hospital for Sick Children at 1 site in India.
Trial summary
The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving package of iron and other micronutrients, to treat infants with iron deficiency anemia in India. Results have implications for programs using Sprinkles worldwide because lower doses of iron may have fewer side effects. Read more about this study
- Who is it for?
- Ages 6 to 18 months
- Conditions the study is for
- Anemia
- What is being tested?
- iron supplement, iron drops
- How many people
- 425 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2004to Jun 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 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-18 months of age
- anemic (Hb 70-100g/L)
- ingesting weaning food in addition to breast milk
- free from major illness (including symptomatic for malaria) and afebrile
- living within study area for the next two months
- parental consent obtained
- only one child per household in the study
Who cannot join
- Hb < 70 or ≥ 100 g/L
- Not receiving any complementary foods
- Receiving an iron supplement within two weeks of the date of enrolment
- chronic illness
- severely malnourished: weight for age z-score < -3.0
- another child in the household is a subject in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India.
The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving package of iron and other micronutrients, to treat infants with iron deficiency anemia in India. Results have implications for programs using Sprinkles worldwide because lower doses of iron may have fewer side effects.
Read the detailed description
Iron deficiency anemia affects two thirds of children in most developing nations, and even mild anemia can have serious implications for child development. In India, government programs within India have been ineffective in controlling this public health problem due to the lack of effective iron supplements reaching children.
Our research group developed 'Sprinkles', an inexpensive micronutrient supplement which is a single-serve sachet of tasteless powder that contain encapsulated iron and other micronutrients. Parents can be easily instructed to mix the contents of one sachet into a bowl of any complementary food.
This study is part of a partnership and capacity development between interdisciplinary research groups at The Hospital for Sick Children, University of Toronto, Canada and the King Edward Memorial Hospital in India, aimed at developing a long-term program of research that will address iron deficiency anemia among infants and young children in India. For Sprinkles to be implemented into national programs in India, a comprehensive strategy is needed which includes a single, safe and effective iron dose for the Indian population.
This specific study is to conduct a community-based, randomized clinical trial in India to determine the appropriate dose of supplementation required for the target age group.
- Conditions
- Anemia
- Being tested
- iron supplement, iron drops
- Keywords
- anemia, iron deficiency, iron drops, iron supplement, malnutrition, pediatrics
- Medical subject headings
- Anemia, Iron Deficiencies, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron supplement, iron dropsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing
Secondary outcomes (4)
Ferritin at 8 weeks
Serum Transferrin Receptor (sTfR) at 8 weeks
side effects every 2 weeks
compliance with iron supplement assessed every 2 weeks
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 startAug 2004
- Study completionJun 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.
- 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
- 425 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Zlotkin, The Hospital for Sick Children
- Investigators
- Stanley Zlotkin, PhD, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213161
- Sponsor's protocol ID
- 1000001031
- Other IDs
- CIHR: GLH-63082
- Status last verified
- Apr 2021
- First submitted
- 13 Sep 2005
- 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
- Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India.
- ClinicalTrials.gov ID
- NCT00213161
- Acronym / sponsor ID
- 1000001031
- Conditions
- Anemia
- Keywords
- anemia, iron deficiency, iron drops, iron supplement, malnutrition, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Jun 2005
- 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 purpose of this study is to determine the smallest dose of Sprinkles, a single-serving package of iron and other micronutrients, to treat infants with iron deficiency anemia in India. Results have implications for programs using Sprinkles worldwide because lower doses of iron may have fewer side effects.
Detailed description
Iron deficiency anemia affects two thirds of children in most developing nations, and even mild anemia can have serious implications for child development. In India, government programs within India have been ineffective in controlling this public health problem due to the lack of effective iron supplements reaching children.
Our research group developed 'Sprinkles', an inexpensive micronutrient supplement which is a single-serve sachet of tasteless powder that contain encapsulated iron and other micronutrients. Parents can be easily instructed to mix the contents of one sachet into a bowl of any complementary food.
This study is part of a partnership and capacity development between interdisciplinary research groups at The Hospital for Sick Children, University of Toronto, Canada and the King Edward Memorial Hospital in India, aimed at developing a long-term program of research that will address iron deficiency anemia among infants and young children in India. For Sprinkles to be implemented into national programs in India, a comprehensive strategy is needed which includes a single, safe and effective iron dose for the Indian population.
This specific study is to conduct a community-based, randomized clinical trial in India to determine the appropriate dose of supplementation required for the target age group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 6-18 months of age
- anemic (Hb 70-100g/L)
- ingesting weaning food in addition to breast milk
- free from major illness (including symptomatic for malaria) and afebrile
- living within study area for the next two months
Key exclusion criteria (6 listed)
- Hb < 70 or ≥ 100 g/L
- Not receiving any complementary foods
- Receiving an iron supplement within two weeks of the date of enrolment
- chronic illness
- severely malnourished: weight for age z-score < -3.0
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 |
|---|---|---|
| iron supplement, iron drops | Drug | – |
Primary outcome
Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing
4 secondary outcomes
Ferritin at 8 weeks
Serum Transferrin Receptor (sTfR) at 8 weeks
side effects every 2 weeks
compliance with iron supplement assessed every 2 weeks
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 Zlotkin, PhD, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iron supplement, iron drops in people with Anemia, run by The Hospital for Sick Children at 1 site in India.
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 6 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 India. 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 at 4 weeks, 8 weeks, 8 months after first dosing. 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.