Impact of Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent

April 14, 2021 updated by: Stanley Zlotkin, The Hospital for Sick Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Mymensingh District
      • Shombhuganj, Mymensingh District, Bangladesh
        • Village of Shombhuganj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • inclusion in a nutrition program in the past
  • chronic illness other than malnutrition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 1
Each child in this group will receive daily supplementation of Iron Sprinkles with a single sachet for 60 days
Dietary supplement: Oral Iron Supplement
Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
Other Names:
  • Sprinkles
PLACEBO_COMPARATOR: 2
Each child in this group will receive daily supplementation of placebo Sprinkles with a single sachet for 60 days
Dietary supplement: Placebo
Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
Other Names:
  • Placebo Sprinkles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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 distinct and consecutive phases of 6 months each

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of death and fever without a source [Safety]
Time Frame: 2 distinct and consecutive phases of 6 months each
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
2 distinct and consecutive phases of 6 months each

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
International Centre for Diarrhoeal Disease Research, Bangladesh
Bangladesh Rural Advancement Committee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stanley Zlotkin, MD, The Hospital for Sick Children, Toronto Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000009576

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malnutrition

Clinical Trials on Oral Iron Supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings