drugset / Trial / NCT00255385
Efficacy of Bifidus DR10 and Oligo Saccharides / Micronutrient Fortification of Milk
Phase 3
Completed
1200 enrolled
Johns Hopkins Bloomberg School of Public Health
Annamalai University · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2002-04
- Primary completion
- —
- Completion
- 2004-04
Outcome
Mixed primary results
paper Overall, there was no effect of prebiotic and probiotic on diarrhea (6% reduction, 95% Confidence Interval [CI]: -1 to 12%; p = 0.08). PMID 20730056 ↗
paper The fortified milk reduced the odds for days with severe illnesses by 15% (95% confidence interval 5% to 24%), the incidence of diarrhoea by 18% (7% to 27%), and the incidence of acute lower respiratory illness by 26% (3% to 43%). PMID 17132678 ↗
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.
- Sazawal 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.
- Sazawal 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.
- Sazawal 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bifidobacterium lactis HN019 | Other / unclassified | 1.9e+07 unknown | Oral |
| Subject | Iron Sulfate | Small molecule | 9.6 mg | Oral |
| Subject | Zinc Sulfate | Unknown | 7.8 mg | Oral |
| Subject | prebiotic oligosaccharide | Oligonucleotide (other) | 2.4 g | Oral |