Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children (NCT00512824) | Clinical Trial Compass
CompletedNot Applicable
Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children
Indonesia494 participantsStarted 2007-08
Plain-language 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.
Who can participate
Age range1 Year – 6 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The mean number of episodes and duration of acute diarrheal disease