MalnutritionPhase 3NCT00530374
Impact of Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent
A Phase 3 study testing Oral Iron Supplement in people with Malnutrition and Iron Deficiency, run by The Hospital for Sick Children at 1 site in Bangladesh.
Trial summary
The purpose of this study is to determine the safety profile of oral iron supplementation (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID) and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated. Read more about this study
- Who is it for?
- Ages 1 year to 2 years
- Conditions the study is for
- Malnutrition, Iron Deficiency
- What is being tested?
- Oral Iron Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteBangladesh
- Study dates
- Nov 2007to Apr 2009
- Phase
- Phase 3
- 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 1 year to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 12 - 24 months
- moderate to severe malnutrition (MSM), defined as weight-for-age Z-score ≤ -2 based on the National Center for Health Statistics (NCHS) standards
- chronic illness other than malnutrition.
Who cannot join
- severe anemia (hemoglobin ≤70g/L)
- near normal hemoglobin concentration (>100g/L)
- weight-for-height <-3 z-score (severe wasting)
- kwashiorkor (defined as evidence of edema)
- congenital abnormality or disease
- treatment with iron supplements in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Oral Iron Supplementation With Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent - A Non-Inferiority Safety Trial
The purpose of this study is to determine the safety profile of oral iron supplementation (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID) and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated.
Read the detailed description
Iron deficiency (ID) affects many children in developing countries. Anemia and impaired brain development are its most significant consequences. These may be prevented by giving oral iron supplements (OIS), such as Sprinkles. ID treatment was controversial because high dose parenteral iron therapy is strongly associated with severe infections when given to severely malnourished children. Many studies have since demonstrated the safety of low dose OIS. WHO guidelines reflect this finding: population-wide iron supplementation campaign (PWISC), without prior screening, is recommended when ID prevalence is ≥ 40%.
However, a gap in the safety evidence has been identified: children with moderate or severe malnutrition (MSM) are strikingly absent from the studies performed to date to investigate the link between OIS and infectious morbidities. In this context, PWISC may have unrecognized deleterious effects when the prevalence of MSM is high, since safety is assumed, but incorrectly extrapolated from available evidence.
We wish to emphasize an additional concern with regards to safety studies published thus far: all were designed as superiority trials. In this context, it is statistically incorrect to conclude that failure to show a significant difference between iron and placebo means that their respective side-effect profiles are similar.
- Conditions
- Malnutrition, Iron Deficiency
- Being tested
- Oral Iron Supplement, Placebo
- Keywords
- Pediatrics, Malnutrition, Iron Deficiency, Sprinkles, Oral Iron Supplementation
- Medical subject headings
- Malnutrition, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Iron SupplementDietary supplement
Also called Sprinkles
Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
PlaceboDietary supplement
Also called Placebo Sprinkles
Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Each child in this group will receive daily supplementation of Iron Sprinkles with a single sachet for 60 days Receives: Dietary Supplement: Oral Iron Supplement |
| 2 | Placebo comparator | Each child in this group will receive daily supplementation of placebo Sprinkles with a single sachet for 60 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite score based on the sum of all distinct episodes of diarrhea, dysentery and lower respiratory tract infections
Measured: 2 distinct and consecutive phases of 6 months each
Secondary outcomes (2)
Incidence of death and fever without a source [Safety]
Measured: 2 distinct and consecutive phases of 6 months each
Change in haemoglobin concentration after Sprinkles supplementation [Efficacy]
Measured: 2 distinct and consecutive phases of 6 months each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh Rural Advancement Committee, International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, Stanley Zlotkin, The Hospital for Sick Children
- Investigators
- Stanley Zlotkin, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530374
- Sponsor's protocol ID
- 1000009576
- Status last verified
- Apr 2021
- First submitted
- 13 Sep 2007
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lemaire M, Islam QS, Shen H, Khan MA, Parveen M, Abedin F, Haseen F, Hyder Z, Cook RJ, Zlotkin SH. Iron-containing micronutrient powder provided to children with moderate-to-severe malnutrition increases hemoglobin concentrations but not the risk of infectious morbidity: a randomized, double-blind, placebo-controlled, noninferiority safety trial. Am J Clin Nutr. 2011 Aug;94(2):585-93. doi: 10.3945/ajcn.110.009316. Epub 2011 Jun 29.
PubMed 21715512
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
- Impact of Oral Iron Supplementation With Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent - A Non-Inferiority Safety Trial
- ClinicalTrials.gov ID
- NCT00530374
- Acronym / sponsor ID
- 1000009576
- Conditions
- Malnutrition, Iron Deficiency
- Keywords
- Pediatrics, Malnutrition, Iron Deficiency, Sprinkles, Oral Iron Supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Bangladesh Rural Advancement Committee, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Nov 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 Sep 2007 (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 safety profile of oral iron supplementation (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID) and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated.
Detailed description
Iron deficiency (ID) affects many children in developing countries. Anemia and impaired brain development are its most significant consequences. These may be prevented by giving oral iron supplements (OIS), such as Sprinkles. ID treatment was controversial because high dose parenteral iron therapy is strongly associated with severe infections when given to severely malnourished children. Many studies have since demonstrated the safety of low dose OIS. WHO guidelines reflect this finding: population-wide iron supplementation campaign (PWISC), without prior screening, is recommended when ID prevalence is ≥ 40%.
However, a gap in the safety evidence has been identified: children with moderate or severe malnutrition (MSM) are strikingly absent from the studies performed to date to investigate the link between OIS and infectious morbidities. In this context, PWISC may have unrecognized deleterious effects when the prevalence of MSM is high, since safety is assumed, but incorrectly extrapolated from available evidence.
We wish to emphasize an additional concern with regards to safety studies published thus far: all were designed as superiority trials. In this context, it is statistically incorrect to conclude that failure to show a significant difference between iron and placebo means that their respective side-effect profiles are similar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Oral Iron SupplementEach child in this group will receive daily supplementation of Iron Sprinkles with a single sachet for 60 days |
| 2 | Placebo comparator | Dietary Supplement: PlaceboEach child in this group will receive daily supplementation of placebo Sprinkles with a single sachet for 60 days |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged 12 - 24 months
- moderate to severe malnutrition (MSM), defined as weight-for-age Z-score ≤ -2 based on the National Center for Health Statistics (NCHS) standards
- chronic illness other than malnutrition.
Key exclusion criteria (6 listed)
- severe anemia (hemoglobin ≤70g/L)
- near normal hemoglobin concentration (>100g/L)
- weight-for-height <-3 z-score (severe wasting)
- kwashiorkor (defined as evidence of edema)
- congenital abnormality or disease
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 |
|---|---|---|
| Oral Iron SupplementAlso: SprinklesIron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days | Dietary supplement | 1 |
| PlaceboAlso: Placebo SprinklesPlacebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days | Dietary supplement | 2 |
Primary outcome
A composite score based on the sum of all distinct episodes of diarrhea, dysentery and lower respiratory tract infections
Time frame: 2 distinct and consecutive phases of 6 months each
2 secondary outcomes
Incidence of death and fever without a source [Safety]
Time frame: 2 distinct and consecutive phases of 6 months each
Change in haemoglobin concentration after Sprinkles supplementation [Efficacy]
Time frame: 2 distinct and consecutive phases of 6 months each
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.
- Derived from this study: PubMed 21715512Lemaire M, Islam QS, Shen H, Khan MA, Parveen M, Abedin F, Haseen F, Hyder Z, Cook RJ, Zlotkin SH. Iron-containing micronutrient powder provided to children with moderate-to-severe malnutrition increases hemoglobin concentrations but not the risk of infectious morbidity: a randomized, double-blind, placebo-controlled, noninferiority safety trial. Am J Clin Nutr. 2011 Aug;94(2):585-93. doi: 10.3945/ajcn.110.009316. Epub 2011 Jun 29.
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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, MD 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 Phase 3 study testing Oral Iron Supplement in people with Malnutrition and Iron Deficiency, 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 3 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 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
A composite score based on the sum of all distinct episodes of diarrhea, dysentery and lower respiratory tract infections (time frame: 2 distinct and consecutive phases of 6 months each). 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 NCT00530374, which also lists 1 linked publication.
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.