Clinical trial NCT00512824: Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children
Official title: Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children Aged 1-6 Years in Low Socio-economic Urban Area of East Jakarta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Diarrhea
Keywords: calcium
probiotics
diarrhea
children
Indonesia
Healthy children
acute diarrhea
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
name: SEAMEO-TROPMED RCCN University of Indonesia
First posted: 2007-08-08
Enrollment: 494
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a long term study on the efficacy of dietary calcium with or without probiotic strains in reducing the mean number of episodes and duration of diarrheal disease.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy children aged 1-6 years, with emphasize on aged 2-5 years, living permanently in low socio-economic urban areas of East Jakarta for at least 6 months
* 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:

* Calcium intake exceeding 75% of the RDA for calcium (\<375 mg/d) based on a Food Frequency Questionnaire
* 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

Primary outcomes:
measure: The mean number of episodes and duration of acute diarrheal disease
timeFrame: 24 weeks
Secondary outcomes:
measure: Incidence of acute diarrheal disease
timeFrame: 24 weeks
measure: Severity of acute diarrheal disease
timeFrame: 24 weeks
measure: Intestinal and systemic inflammation
timeFrame: 24 weeks
measure: Intestinal colonization with pathogenic bacteria or viruses
timeFrame: 24 weeks
measure: Nutritional status based on anthropometric measurement
timeFrame: 24 weeks
measure: Iron and zinc status
timeFrame: 24 weeks
measure: Incidence, mean episodes and duration of acute respiratory infections
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Seameo-Tropmed Rccn Ui
Study officials:
affiliation: SEAMEO-TROPMED RCCN UI
name: Rina Agustina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Human Nutrition, Wageningen University (WUR)
name: Frans J. Kok, Prof
role: STUDY_CHAIR
affiliation: TIFN/ NIZO Food Research
name: Ingeborg Bovee-Oudenhoven, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine University of Indonesia
name: Agus Firmansyah, Prof, MD
role: STUDY_CHAIR
affiliation: SEAMEO-TROPMED RCCN UI
name: Widjaja Lukito, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.