Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

Study Overview
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Brief Summary
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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.

Official Title
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Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children Aged 1-6 Years in Low Socio-economic Urban Area of East Jakarta

Conditions
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Healthy, Diarrhea

Intervention / Treatment
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* Dietary Supplement: low calcium milk of 180 ml
* Dietary Supplement: regular milk of 180 ml
* Dietary Supplement: regular milk of 180 ml + probiotics
* Dietary Supplement: regular milk of 180 ml + probiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Dietary Supplement: low calcium milk of 180 ml<br>* twice daily for 24 weeks<br>|
| Active Comparator: 2<br> | Dietary Supplement: regular milk of 180 ml<br>* twice daily for 24 weeks<br>|
| Active Comparator: 3<br> | Dietary Supplement: regular milk of 180 ml + probiotics<br>* twice daily for 24 weeks<br>|
| Active Comparator: 4<br> | Dietary Supplement: regular milk of 180 ml + probiotics<br>* twice daily for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean number of episodes and duration of acute diarrheal disease |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute diarrheal disease |  | 24 weeks | 
| Severity of acute diarrheal disease |  | 24 weeks | 
| Intestinal and systemic inflammation |  | 24 weeks | 
| Intestinal colonization with pathogenic bacteria or viruses |  | 24 weeks | 
| Nutritional status based on anthropometric measurement |  | 24 weeks | 
| Iron and zinc status |  | 24 weeks | 
| Incidence, mean episodes and duration of acute respiratory infections |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcium, probiotics, diarrhea, children, Indonesia, Healthy children, acute diarrhea