Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children
NCT ID: NCT00512824
Last Updated: 2011-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
494 participants
INTERVENTIONAL
2007-08-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
low calcium milk of 180 ml
twice daily for 24 weeks
2
regular milk of 180 ml
twice daily for 24 weeks
3
regular milk of 180 ml + probiotics
twice daily for 24 weeks
4
regular milk of 180 ml + probiotics
twice daily for 24 weeks
Interventions
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low calcium milk of 180 ml
twice daily for 24 weeks
regular milk of 180 ml
twice daily for 24 weeks
regular milk of 180 ml + probiotics
twice daily for 24 weeks
regular milk of 180 ml + probiotics
twice daily for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* Parents are willing to sign the informed consent and give the supplements to the children for the period of 6 months
* Capable and willing to drink liquid milk with a straw (acceptance to be tested at screening by providing a sample drink and placebo straw to be consumed under supervision for 2 days)
Exclusion Criteria
* Currently breastfed children
* Siblings of already included children that are living in the same household, except if it is a twin sibling
* Severely malnourished with or without oedema (Weight for height-WHZ Z-score of \<-3.00 SD)
* Symptoms of chronic/congenital diseases and disabilities, suspected Tuberculosis by clinical examination, and /or history of allergic disease.
* Taking (any) antibiotics during 2 weeks prior to start of the study (children will be included after 3 weeks of last antibiotic intake
* Participation in another clinical trial at the same time or 2 months prior to the start of this study
* Both mothers and other caregivers present in the family are illiterate
1 Year
6 Years
ALL
Yes
Sponsors
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Top Institute Food and Nutrition
OTHER
SEAMEO-TROPMED RCCN University of Indonesia
UNKNOWN
Wageningen University
OTHER
Responsible Party
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Top Institute Food and Nutrition
Principal Investigators
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Rina Agustina, MD
Role: PRINCIPAL_INVESTIGATOR
SEAMEO-TROPMED RCCN UI
Frans J. Kok, Prof
Role: STUDY_CHAIR
Division of Human Nutrition, Wageningen University (WUR)
Ingeborg Bovee-Oudenhoven, PhD
Role: STUDY_DIRECTOR
TIFN/ NIZO Food Research
Agus Firmansyah, Prof, MD
Role: STUDY_CHAIR
Faculty of Medicine University of Indonesia
Widjaja Lukito, MD
Role: STUDY_DIRECTOR
SEAMEO-TROPMED RCCN UI
Locations
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Seameo-Tropmed Rccn Ui
Jakarta, Jakarta Special Capital Region, Indonesia
Countries
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References
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Agustina R, Bovee-Oudenhoven IM, Lukito W, Fahmida U, van de Rest O, Zimmermann MB, Firmansyah A, Wulanti R, Albers R, van den Heuvel EG, Kok FJ. Probiotics Lactobacillus reuteri DSM 17938 and Lactobacillus casei CRL 431 modestly increase growth, but not iron and zinc status, among Indonesian children aged 1-6 years. J Nutr. 2013 Jul;143(7):1184-93. doi: 10.3945/jn.112.166397. Epub 2013 May 22.
Agustina R, Kok FJ, van de Rest O, Fahmida U, Firmansyah A, Lukito W, Feskens EJ, van den Heuvel EG, Albers R, Bovee-Oudenhoven IM. Randomized trial of probiotics and calcium on diarrhea and respiratory tract infections in Indonesian children. Pediatrics. 2012 May;129(5):e1155-64. doi: 10.1542/peds.2011-1379. Epub 2012 Apr 9.
Other Identifiers
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A011-CPDI
Identifier Type: -
Identifier Source: org_study_id
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