StuntingPhase 2/3JiVitA-6NCT03683667
Protein Plus: Improving Infant Growth Through Diet and Enteric Health
A Phase 2/3 study testing Azithromycin Oral Product, Protein Supplement and Isocaloric Supplement in people with Stunting and Malnutrition; Protein, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
Trial summary
This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens. Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Stunting, Malnutrition; Protein, Enteric Pathogens
- What is being tested?
- Azithromycin Oral Product, Protein Supplement and Isocaloric Supplement
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,283 participants
- Where
- 1 siteBangladesh
- Study dates
- 23 Sep 2018to 24 Mar 2020
- Phase
- Phase 2/3
- 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 3 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born to women enrolled in ongoing community trial (NCT02909179) over a one-year period
Who cannot join
- Born to women not registered as part of the ongoing community trial (NCT02909179)
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
JiVitA Maternal and Child & Nutrition Research Site
Gaibandha
About this study
Official title: Efficacy of Supplemental Protein, Delivered Alone or in Combination With Treatment for Enteric Pathogens, to Prevent Growth Faltering in Bangladeshi Infants
This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens.
Read the detailed description
Stunting a major public health problem in Bangladesh, where 36% of children under the age of five are too short for their age. While dietary data indicate that protein intakes of infants and young children are largely in line with requirements, the extent to which requirements derived for healthy infants and young children are relevant in the context of frequent infections remains an important research question.
Recent investigations indicate widespread pathogen carriage among Bangladeshi infants, with virtually all having at least one detectable pathogen in nondiarrheal stools by six months of age. Campylobacter and pathogenic E. Coli predominate in this setting. Enteric pathogens can compete with the host for available nutrients or alter nutrient metabolism. Acting via environmental enteric dysfunction, they can alter both digestion-through loss of digestive enzymes-and absorption of nutrients. Microbial translocation may further alter specific amino acid requirements.
Even in the absence of acute diarrheal disease, enteric pathogen carriage is strongly associated with linear growth faltering. Combining the effects of high pathogen burden and poor diet, as indicated by low energy and protein from complementary foods, observational evidence suggests that the potentially preventable length-for-age Z-score deficit may be as high as 0.98.
The present trial will test the combination of a) protein supplementation in the form of a protein-rich blended food or an egg, both fed daily to infants 6-12 months of age, and b) azithromycin treatment for enteric pathogens. The primary outcome will be change in length-for-age Z-score from the 6 to 12 months. Biochemical, microbiological and clinical intermediates will be measured to inform our secondary aims.
- Being tested
- Azithromycin Oral Product, Placebos, Protein Supplement, Isocaloric Supplement, Egg
- Keywords
- linear growth, infant feeding, environmental enteric dysfunction
- Medical subject headings
- Growth Disorders, Kwashiorkor, Campylobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin Oral ProductDrug
Also called Azithrocin
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
PlacebosDrug
Contain inert excipients only
Protein SupplementDietary supplement
Blended food providing 125 kcal and 10 g protein as egg white powder prepared as porridge and fed daily to infants from 6-12 months of age
Isocaloric SupplementDietary supplement
Blended food providing 125 kcal and 1 g protein as rice powder prepared as porridge and fed daily to infants from 6-12 months of age
EggDietary supplement
Egg provided daily to infants from 6-12 months of age
Nutrition EducationBehavioural
Monthly messaging on infant and young child feeding
| Study group | Role | What they receive |
|---|---|---|
| Placebo & Control | Placebo comparator | Placebo / Nutrition education Receives: Drug: Placebos; Behavioral: Nutrition Education |
| Placebo & Protein Supplement | Experimental | Placebo / Protein-rich blended food / Nutrition education Receives: Drug: Placebos; Dietary Supplement: Protein Supplement; Behavioral: Nutrition Education |
| Placebo & Isocaloric Supplement | Placebo comparator | Placebo / Isocaloric blended food / Nutrition education Receives: Drug: Placebos; Dietary Supplement: Isocaloric Supplement; Behavioral: Nutrition Education |
| Placebo & Egg | Experimental | Placebo / Egg / Nutrition education Receives: Drug: Placebos; Dietary Supplement: Egg; Behavioral: Nutrition Education |
| Azithromycin & Control | Experimental | Azithromycin / Nutrition education Receives: Drug: Azithromycin Oral Product; Behavioral: Nutrition Education |
| Azithromycin & Protein Supplement | Experimental | Azithromycin / Protein-rich blended food / Nutrition education Receives: Drug: Azithromycin Oral Product; Dietary Supplement: Protein Supplement; Behavioral: Nutrition Education |
| Azithromycin & Isocaloric Supplement | Experimental | Azithromycin Isocaloric blended food Nutrition education Receives: Drug: Azithromycin Oral Product; Dietary Supplement: Isocaloric Supplement; Behavioral: Nutrition Education |
| Azithromycin and Egg | Experimental | Azithromycin Egg Nutrition education Receives: Drug: Azithromycin Oral Product; Dietary Supplement: Egg; Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length-for-age Z-score (LAZ) at 12 months of age
Measured: 12 months
Secondary outcomes (10)
Nutrient biomarkers
Serum essential, conditionally essential amino acids and choline (by metabolomic analysis); retinol and tocopherols (HPLC); vitamin B12 (microbiological assay); zinc (AAS); ferritin and thyroglobulin (ELISA)
Measured: 6 and 12 months
Growth hormone and stress axes biomarkers
Serum insulin-like growth factor 1 (IGF-1), IGF binding protein 3, cortisol, by ELISA
Measured: 6 and 12 months
Enteropathogen burden
Campylobacter, enterotoxigenic Escherichia coli (ETEC), enteroaggregative Escherichia coli (EAEC), enteropathogenic Escherichia coli (EPEC), Shigella and Cryptosporidium, by quantitative polymerase chain reaction (qPCR)
Measured: 6, 6.5, 9, 9.5, 12, 15, and 18 months
Gut microbiota composition
Microbial diversity and abundance, by 16S ribosomal RNA sequencing
Measured: 6, 6.5, 9, 9.5, 12, 15, and 18 months
Environmental enteric dysfunction biomarkers
Stool myeloperoxidase and intestinal fatty acid-binding protein concentrations and plasma Endogenous endotoxin-core antibody (EndoCAb), by ELISA
Measured: 6 and 12 months
Inflammatory biomarkers
Plasma alpha-1 acid glycoprotein, C-reactive protein and interleukin-6, by ELISA; stool inflammatory cytokines, by ELISA
Measured: 6 and 12 months
Bone biomarkers
Plasma collagen type X and N-Terminal Pro-C-Type Natriuretic Peptide (NT-ProCNP), by ELISA
Measured: 6 and 12 months
Morbidity incidence
Incident diarrhea/dysentery or respiratory infection, based on weekly recalls
Measured: 6-12 months
Body composition
Fat mass by bioelectrical impedence
Measured: 6, 9, 12, 15, and 18 months
Antibiotic resistance
Resistance of commensal E. coli (stool) or S. pneumoniae (nasopharyngeal swab) to panel of antibiotics, by culture
Measured: 6, 9, 12, 15, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start23 Sep 2018
- Primary completion19 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- For this 2 x 4 factorial, cluster-randomized trial, 566 previously defined clusters will be assigned independently to 8 different combinations of interventions: 1) azithromycin and protein supplementation; 2) azithromycin and isocaloric supplementation; 3) azithromycin and egg; 4) azithromycin and control (nutrition education); 5) placebo and protein supplementation; 6) placebo and isocaloric supplementation; 7) placebo and egg; 8) placebo and control (nutrition education).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Amanda C Palmer, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthMd Iqbal Hossain, PhD, Principal investigator, International Centre for Diarrhoel Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683667
- Sponsor's protocol ID
- 00008000
- Other IDs
- OPP1163259
- Acronym
- JiVitA-6
- Status last verified
- Dec 2022
- First submitted
- 21 Sep 2018
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arsenault JE, Brown KH. Dietary Protein Intake in Young Children in Selected Low-Income Countries Is Generally Adequate in Relation to Estimated Requirements for Healthy Children, Except When Complementary Food Intake Is Low. J Nutr. 2017 May;147(5):932-939. doi: 10.3945/jn.116.239657. Epub 2017 Feb 15.
PubMed 28202639Uauy R. Keynote: rethinking protein. Food Nutr Bull. 2013 Jun;34(2):228-31. doi: 10.1177/156482651303400213. No abstract available.
PubMed 23964397Lang D; MAL-ED Network Investigators. Opportunities to assess factors contributing to the development of the intestinal microbiota in infants living in developing countries. Microb Ecol Health Dis. 2015 May 29;26:28316. doi: 10.3402/mehd.v26.28316. eCollection 2015.
PubMed 26031686MAL-ED Network Investigators. Relationship between growth and illness, enteropathogens and dietary intakes in the first 2 years of life: findings from the MAL-ED birth cohort study. BMJ Glob Health. 2017 Dec 28;2(4):e000370. doi: 10.1136/bmjgh-2017-000370. eCollection 2017.
PubMed 29333282Palmer AC, Hossain MI, Ali H, Ayesha K, Shaikh S, Islam MT, Johura FT, Pasqualino MM, Rahman H, Haque R, Alland K, Wu LS, Schulze KJ, Chakraborty S, West KP Jr, Alam M, Ahmed T, Labrique AB. Protein supplementation delivered alone or in combination with presumptive azithromycin treatment for enteric pathogens did not improve linear growth in Bangladeshi infants: results of a cluster-randomized controlled trial. Am J Clin Nutr. 2025 Mar;121(3):597-609. doi: 10.1016/j.ajcnut.2024.12.027. Epub 2025 Jan 7.
PubMed 39788294Pasqualino MM, Shaikh S, Hossain MI, Islam MT, Ali H, Haque R, Ayesha K, Wu LS, Dyer B, Hasan K, Alland K, Schulze KJ, Johura FT, Alam M, West KP Jr, Ahmed T, Labrique AB, Palmer AC. An Egg Intervention Improves Ponderal But Not Linear Growth Among Infants 6-12 mo of Age in Rural Bangladesh. J Nutr. 2024 Jul;154(7):2290-2299. doi: 10.1016/j.tjnut.2024.05.006. Epub 2024 May 15.
PubMed 38759886Tong H, Thorne-Lyman A, Palmer AC, Shaikh S, Ali H, Gao Y, Pasqualino MM, Wu L, Alland K, Schulze K, West KP Jr, Hossain MI, Labrique AB. Prelacteal feeding is not associated with infant size at 3 months in rural Bangladesh: a prospective cohort study. Int Breastfeed J. 2024 Feb 27;19(1):15. doi: 10.1186/s13006-024-00621-4.
PubMed 38413997
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Supplemental Protein, Delivered Alone or in Combination With Treatment for Enteric Pathogens, to Prevent Growth Faltering in Bangladeshi Infants
- ClinicalTrials.gov ID
- NCT03683667
- Acronym / sponsor ID
- JiVitA-6 / 00008000
- Keywords
- linear growth, infant feeding, environmental enteric dysfunction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,283 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Bill and Melinda Gates Foundation
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 25 Sep 2018 (actual)
- 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.
This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens.
Detailed description
Stunting a major public health problem in Bangladesh, where 36% of children under the age of five are too short for their age. While dietary data indicate that protein intakes of infants and young children are largely in line with requirements, the extent to which requirements derived for healthy infants and young children are relevant in the context of frequent infections remains an important research question.
Recent investigations indicate widespread pathogen carriage among Bangladeshi infants, with virtually all having at least one detectable pathogen in nondiarrheal stools by six months of age. Campylobacter and pathogenic E. Coli predominate in this setting. Enteric pathogens can compete with the host for available nutrients or alter nutrient metabolism. Acting via environmental enteric dysfunction, they can alter both digestion-through loss of digestive enzymes-and absorption of nutrients. Microbial translocation may further alter specific amino acid requirements.
Even in the absence of acute diarrheal disease, enteric pathogen carriage is strongly associated with linear growth faltering. Combining the effects of high pathogen burden and poor diet, as indicated by low energy and protein from complementary foods, observational evidence suggests that the potentially preventable length-for-age Z-score deficit may be as high as 0.98.
The present trial will test the combination of a) protein supplementation in the form of a protein-rich blended food or an egg, both fed daily to infants 6-12 months of age, and b) azithromycin treatment for enteric pathogens. The primary outcome will be change in length-for-age Z-score from the 6 to 12 months. Biochemical, microbiological and clinical intermediates will be measured to inform our secondary aims.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- For this 2 x 4 factorial, cluster-randomized trial, 566 previously defined clusters will be assigned independently to 8 different combinations of interventions: 1) azithromycin and protein supplementation; 2) azithromycin and isocaloric supplementation; 3) azithromycin and egg; 4) azithromycin and control (nutrition education); 5) placebo and protein supplementation; 6) placebo and isocaloric supplementation; 7) placebo and egg; 8) placebo and control (nutrition education).
| Arm | Type | Receives |
|---|---|---|
| Placebo & Control | Placebo comparator | Drug: Placebos, Behavioral: Nutrition EducationPlacebo / Nutrition education |
| Placebo & Protein Supplement | Experimental | Drug: Placebos, Dietary Supplement: Protein Supplement, Behavioral: Nutrition EducationPlacebo / Protein-rich blended food / Nutrition education |
| Placebo & Isocaloric Supplement | Placebo comparator | Drug: Placebos, Dietary Supplement: Isocaloric Supplement, Behavioral: Nutrition EducationPlacebo / Isocaloric blended food / Nutrition education |
| Placebo & Egg | Experimental | Drug: Placebos, Dietary Supplement: Egg, Behavioral: Nutrition EducationPlacebo / Egg / Nutrition education |
| Azithromycin & Control | Experimental | Drug: Azithromycin Oral Product, Behavioral: Nutrition EducationAzithromycin / Nutrition education |
| Azithromycin & Protein Supplement | Experimental | Drug: Azithromycin Oral Product, Dietary Supplement: Protein Supplement, Behavioral: Nutrition EducationAzithromycin / Protein-rich blended food / Nutrition education |
| Azithromycin & Isocaloric Supplement | Experimental | Drug: Azithromycin Oral Product, Dietary Supplement: Isocaloric Supplement, Behavioral: Nutrition EducationAzithromycin Isocaloric blended food Nutrition education |
| Azithromycin and Egg | Experimental | Drug: Azithromycin Oral Product, Dietary Supplement: Egg, Behavioral: Nutrition EducationAzithromycin Egg Nutrition education |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Born to women enrolled in ongoing community trial (NCT02909179) over a one-year period
Key exclusion criteria (1 listed)
- Born to women not registered as part of the ongoing community trial (NCT02909179)
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 |
|---|---|---|
| Azithromycin Oral ProductAlso: AzithrocinAzithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age | Drug | Azithromycin & Control, Azithromycin & Isocaloric Supplement, Azithromycin & Protein Supplement, Azithromycin and Egg |
| PlacebosContain inert excipients only | Drug | Placebo & Control, Placebo & Egg, Placebo & Isocaloric Supplement, Placebo & Protein Supplement |
| Protein SupplementBlended food providing 125 kcal and 10 g protein as egg white powder prepared as porridge and fed daily to infants from 6-12 months of age | Dietary supplement | Azithromycin & Protein Supplement, Placebo & Protein Supplement |
| Isocaloric SupplementBlended food providing 125 kcal and 1 g protein as rice powder prepared as porridge and fed daily to infants from 6-12 months of age | Dietary supplement | Azithromycin & Isocaloric Supplement, Placebo & Isocaloric Supplement |
| EggEgg provided daily to infants from 6-12 months of age | Dietary supplement | Azithromycin and Egg, Placebo & Egg |
| Nutrition EducationMonthly messaging on infant and young child feeding | Behavioural | Azithromycin & Control, Azithromycin & Isocaloric Supplement, Azithromycin & Protein Supplement, Azithromycin and Egg, Placebo & Control, Placebo & Egg, Placebo & Isocaloric Supplement, Placebo & Protein Supplement |
Primary outcome
Length-for-age Z-score (LAZ) at 12 months of age
Time frame: 12 months
10 secondary outcomes
Nutrient biomarkers
Time frame: 6 and 12 months
Growth hormone and stress axes biomarkers
Time frame: 6 and 12 months
Enteropathogen burden
Time frame: 6, 6.5, 9, 9.5, 12, 15, and 18 months
Gut microbiota composition
Time frame: 6, 6.5, 9, 9.5, 12, 15, and 18 months
Environmental enteric dysfunction biomarkers
Time frame: 6 and 12 months
Inflammatory biomarkers
Time frame: 6 and 12 months
Bone biomarkers
Time frame: 6 and 12 months
Morbidity incidence
Time frame: 6-12 months
Body composition
Time frame: 6, 9, 12, 15, and 18 months
Antibiotic resistance
Time frame: 6, 9, 12, 15, and 18 months
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 5 Dec 2022.
- Background: PubMed 28202639Arsenault JE, Brown KH. Dietary Protein Intake in Young Children in Selected Low-Income Countries Is Generally Adequate in Relation to Estimated Requirements for Healthy Children, Except When Complementary Food Intake Is Low. J Nutr. 2017 May;147(5):932-939. doi: 10.3945/jn.116.239657. Epub 2017 Feb 15.
- Background: PubMed 23964397Uauy R. Keynote: rethinking protein. Food Nutr Bull. 2013 Jun;34(2):228-31. doi: 10.1177/156482651303400213. No abstract available.
- Background: PubMed 26031686Lang D; MAL-ED Network Investigators. Opportunities to assess factors contributing to the development of the intestinal microbiota in infants living in developing countries. Microb Ecol Health Dis. 2015 May 29;26:28316. doi: 10.3402/mehd.v26.28316. eCollection 2015.
- Background: PubMed 29333282MAL-ED Network Investigators. Relationship between growth and illness, enteropathogens and dietary intakes in the first 2 years of life: findings from the MAL-ED birth cohort study. BMJ Glob Health. 2017 Dec 28;2(4):e000370. doi: 10.1136/bmjgh-2017-000370. eCollection 2017.
- Derived from this study: PubMed 39788294Palmer AC, Hossain MI, Ali H, Ayesha K, Shaikh S, Islam MT, Johura FT, Pasqualino MM, Rahman H, Haque R, Alland K, Wu LS, Schulze KJ, Chakraborty S, West KP Jr, Alam M, Ahmed T, Labrique AB. Protein supplementation delivered alone or in combination with presumptive azithromycin treatment for enteric pathogens did not improve linear growth in Bangladeshi infants: results of a cluster-randomized controlled trial. Am J Clin Nutr. 2025 Mar;121(3):597-609. doi: 10.1016/j.ajcnut.2024.12.027. Epub 2025 Jan 7.
- Derived from this study: PubMed 38759886Pasqualino MM, Shaikh S, Hossain MI, Islam MT, Ali H, Haque R, Ayesha K, Wu LS, Dyer B, Hasan K, Alland K, Schulze KJ, Johura FT, Alam M, West KP Jr, Ahmed T, Labrique AB, Palmer AC. An Egg Intervention Improves Ponderal But Not Linear Growth Among Infants 6-12 mo of Age in Rural Bangladesh. J Nutr. 2024 Jul;154(7):2290-2299. doi: 10.1016/j.tjnut.2024.05.006. Epub 2024 May 15.
- Derived from this study: PubMed 38413997Tong H, Thorne-Lyman A, Palmer AC, Shaikh S, Ali H, Gao Y, Pasqualino MM, Wu L, Alland K, Schulze K, West KP Jr, Hossain MI, Labrique AB. Prelacteal feeding is not associated with infant size at 3 months in rural Bangladesh: a prospective cohort study. Int Breastfeed J. 2024 Feb 27;19(1):15. doi: 10.1186/s13006-024-00621-4.
- Individual participant dataSharing planned: No
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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.
Amanda C Palmer, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
Md Iqbal Hossain, PhD principal investigator
International Centre for Diarrhoel Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Azithromycin Oral Product, Protein Supplement and Isocaloric Supplement in people with Stunting and Malnutrition; Protein, run by Johns Hopkins Bloomberg School of Public Health 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 1 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 5 Dec 2022. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Length-for-age Z-score (LAZ) at 12 months of age (time frame: 12 months). 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 NCT03683667, which also lists 7 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 5 Dec 2022.