DiarrheaPhase 3NCT00255385
Efficacy of Bifidus DR10 and Oligo Saccharides / Micronutrient Fortification of Milk
A Phase 3 study testing Micronutrient (Zinc and Iron) fortification and Pre and Probiotic fortification in people with Diarrhea and Pneumonia, run by Johns Hopkins Bloomberg School of Public Health at 1 site in India.
Trial summary
The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Diarrhea, Pneumonia, Febrile Illness
- What is being tested?
- Micronutrient (Zinc and Iron) fortification and Pre and Probiotic fortification
- How many people
- 1,200 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2002to Apr 2004
- 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 12 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 12-36 months at enrollment
- Resident of Sangam Vihar and likely to be in the area for 1 year.
- Parents consenting to participate in the trial.
Who cannot join
- Children who have been given complete therapeutic/preventive course of Iron in the last 6 months.
- Children currently as part of a different Iron/Zinc supplementation program.
- Children known to be allergic to milk.
- Children who are severely malnourished and requiring hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months
The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.
Read the detailed description
The 1993 World Bank World Development Report (1) delivered a strong but sad reminder of the dramatic scale of suffering and death among preschool children attributable to pneumonia (2.7million in 1990) and diarrhea (another 2.5million deaths). In terms of "disability adjusted life years" (DALYS) lost, in 0-4 years old children, respiratory infections account for 18.5% and 17.6% (in boys \& girls respectively) and diarrhea accounts of another 16.2% and 15.7% respectively. The development of effective interventions to reduce morbidity from these illnesses has become a humanitarian, economic and political imperative and essential in achieving the morbidity and mortality reduction goals that the "World Summit for Children" set a decade ago. Therapy with Oral Rehydration Solution (ORS) for diarrhea, a cornerstone of the universal strategy for child survival, has low compliance due to having no effect on duration of diarrhea and has mixed impact on child mortality (2-5). Present strategies for containing morbidity and mortality due to respiratory infection focuses primarily on antibiotic treatment. Increasing prevalence of antibiotic resistant strains, poses a problem with the current strategy. Lack of any truly effective and affordable preventive vaccine, for both diarrhea and pneumonia has aroused considerable interest in food based preventive interventions. In the recent years increasing recognition and evidence regarding the role of Probiotics, and micronutrients like Zinc, as both preventive and therapeutic agents against infections has made them a potential and promising candidate. This study is in fact two trial run concurrently with two milk preparation one fortified with pre and Probiotics and second fortified with micronutrients and each having same milk unfortified as control.
- Conditions
- Diarrhea, Pneumonia, Febrile Illness, Growth, Child Development
- Being tested
- Micronutrient (Zinc and Iron) fortification, Pre and Probiotic fortification
- Keywords
- Zinc, Iron, Probiotics, Prebiotics, Child health, Milk fortification, Randomized controlled trial
- Medical subject headings
- Diarrhea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronutrient (Zinc and Iron) fortificationDrug
Pre and Probiotic fortificationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea
Pneumonia
Febrile illness
Growth
Development
Activity
Secondary outcomes (4)
Iron status
Zinc status
Colonization
Copper status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2005 (estimated)
- Study startApr 2002
- Study completionApr 2004
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 DiarrheaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Annamalai University
- Investigators
- Sunil Sazawal, MD, MPH, PHD, Principal investigator, Johns Hopkins UniversityVenuGopal P Menon, PhD, Principal investigator, Annamalai UniversityRobert E Black, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255385
- Sponsor's protocol ID
- H22010703A
- Status last verified
- Apr 2005
- First submitted
- 16 Nov 2005
- Last updated
- 18 Nov 2005
- Results posted
- No
Publications
Sazawal S, Dhingra U, Dhingra P, Dutta A, Shabir H, Menon VP, Black RE. Efficiency of red cell distribution width in identification of children aged 1-3 years with iron deficiency anemia against traditional hematological markers. BMC Pediatr. 2014 Jan 15;14:8. doi: 10.1186/1471-2431-14-8.
PubMed 24428927Sazawal S, Dhingra U, Dhingra P, Hiremath G, Sarkar A, Dutta A, Menon VP, Black RE. Micronutrient fortified milk improves iron status, anemia and growth among children 1-4 years: a double masked, randomized, controlled trial. PLoS One. 2010 Aug 13;5(8):e12167. doi: 10.1371/journal.pone.0012167.
PubMed 20730057Sazawal S, Dhingra U, Hiremath G, Sarkar A, Dhingra P, Dutta A, Verma P, Menon VP, Black RE. Prebiotic and probiotic fortified milk in prevention of morbidities among children: community-based, randomized, double-blind, controlled trial. PLoS One. 2010 Aug 13;5(8):e12164. doi: 10.1371/journal.pone.0012164.
PubMed 20730056Sazawal S, Dhingra U, Dhingra P, Hiremath G, Kumar J, Sarkar A, Menon VP, Black RE. Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial. BMJ. 2007 Jan 20;334(7585):140. doi: 10.1136/bmj.39035.482396.55. Epub 2006 Nov 28.
PubMed 17132678
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months
- ClinicalTrials.gov ID
- NCT00255385
- Acronym / sponsor ID
- H22010703A
- Conditions
- Diarrhea, Pneumonia, Febrile Illness, Growth, Child Development
- Keywords
- Zinc, Iron, Probiotics, Prebiotics, Child health, Milk fortification, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Annamalai University
- Study start
- Apr 2002
- Study completion
- Apr 2004
- First posted
- 18 Nov 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 the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.
Detailed description
The 1993 World Bank World Development Report (1) delivered a strong but sad reminder of the dramatic scale of suffering and death among preschool children attributable to pneumonia (2.7million in 1990) and diarrhea (another 2.5million deaths). In terms of "disability adjusted life years" (DALYS) lost, in 0-4 years old children, respiratory infections account for 18.5% and 17.6% (in boys \& girls respectively) and diarrhea accounts of another 16.2% and 15.7% respectively. The development of effective interventions to reduce morbidity from these illnesses has become a humanitarian, economic and political imperative and essential in achieving the morbidity and mortality reduction goals that the "World Summit for Children" set a decade ago. Therapy with Oral Rehydration Solution (ORS) for diarrhea, a cornerstone of the universal strategy for child survival, has low compliance due to having no effect on duration of diarrhea and has mixed impact on child mortality (2-5). Present strategies for containing morbidity and mortality due to respiratory infection focuses primarily on antibiotic treatment. Increasing prevalence of antibiotic resistant strains, poses a problem with the current strategy. Lack of any truly effective and affordable preventive vaccine, for both diarrhea and pneumonia has aroused considerable interest in food based preventive interventions. In the recent years increasing recognition and evidence regarding the role of Probiotics, and micronutrients like Zinc, as both preventive and therapeutic agents against infections has made them a potential and promising candidate. This study is in fact two trial run concurrently with two milk preparation one fortified with pre and Probiotics and second fortified with micronutrients and each having same milk unfortified as control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 12-36 months at enrollment
- Resident of Sangam Vihar and likely to be in the area for 1 year.
- Parents consenting to participate in the trial.
Key exclusion criteria (4 listed)
- Children who have been given complete therapeutic/preventive course of Iron in the last 6 months.
- Children currently as part of a different Iron/Zinc supplementation program.
- Children known to be allergic to milk.
- Children who are severely malnourished and requiring hospitalization.
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 |
|---|---|---|
| Micronutrient (Zinc and Iron) fortification | Drug | – |
| Pre and Probiotic fortification | Drug | – |
Primary outcome
Diarrhea
Pneumonia
Febrile illness
Growth
Development
Activity
4 secondary outcomes
Iron status
Zinc status
Colonization
Copper status
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 18 Nov 2005.
- Derived from this study: PubMed 24428927Sazawal S, Dhingra U, Dhingra P, Dutta A, Shabir H, Menon VP, Black RE. Efficiency of red cell distribution width in identification of children aged 1-3 years with iron deficiency anemia against traditional hematological markers. BMC Pediatr. 2014 Jan 15;14:8. doi: 10.1186/1471-2431-14-8.
- Derived from this study: PubMed 20730057Sazawal S, Dhingra U, Dhingra P, Hiremath G, Sarkar A, Dutta A, Menon VP, Black RE. Micronutrient fortified milk improves iron status, anemia and growth among children 1-4 years: a double masked, randomized, controlled trial. PLoS One. 2010 Aug 13;5(8):e12167. doi: 10.1371/journal.pone.0012167.
- Derived from this study: PubMed 20730056Sazawal S, Dhingra U, Hiremath G, Sarkar A, Dhingra P, Dutta A, Verma P, Menon VP, Black RE. Prebiotic and probiotic fortified milk in prevention of morbidities among children: community-based, randomized, double-blind, controlled trial. PLoS One. 2010 Aug 13;5(8):e12164. doi: 10.1371/journal.pone.0012164.
- Derived from this study: PubMed 17132678Sazawal S, Dhingra U, Dhingra P, Hiremath G, Kumar J, Sarkar A, Menon VP, Black RE. Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial. BMJ. 2007 Jan 20;334(7585):140. doi: 10.1136/bmj.39035.482396.55. Epub 2006 Nov 28.
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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.
Sunil Sazawal, MD, MPH, PHD principal investigator
Johns Hopkins University
VenuGopal P Menon, PhD principal investigator
Annamalai University
Robert E Black, MD, MPH principal investigator
Johns Hopkins University
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 Micronutrient (Zinc and Iron) fortification and Pre and Probiotic fortification in people with Diarrhea and Pneumonia, run by Johns Hopkins Bloomberg School of Public Health 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 3 inclusion and 4 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 18 Nov 2005. 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.
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?
Diarrhea. The study lists 6 primary outcomes in all. 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 NCT00255385, 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 18 Nov 2005.