Diarrhea, Healthy
Conditions
Keywords
calcium, probiotics, diarrhea, children, Indonesia, Healthy children, acute diarrhea
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.
Interventions
DIETARY_SUPPLEMENTlow calcium milk of 180 ml
twice daily for 24 weeks
DIETARY_SUPPLEMENTregular milk of 180 ml
twice daily for 24 weeks
DIETARY_SUPPLEMENTregular milk of 180 ml + probiotics
twice daily for 24 weeks
Sponsors
Top Institute Food and Nutrition
SEAMEO-TROPMED RCCN University of Indonesia
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean number of episodes and duration of acute diarrheal disease | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of acute diarrheal disease | 24 weeks |
| Severity of acute diarrheal disease | 24 weeks |
| Intestinal and systemic inflammation | 24 weeks |
| Incidence, mean episodes and duration of acute respiratory infections | 24 weeks |
| Nutritional status based on anthropometric measurement | 24 weeks |
| Iron and zinc status | 24 weeks |
| Intestinal colonization with pathogenic bacteria or viruses | 24 weeks |
Countries
Indonesia
Outcome results
None listed