Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children
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ClinicalTrials.gov Identifier: NCT00512824 |
Recruitment Status :
Completed
First Posted : August 8, 2007
Last Update Posted : January 10, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Diarrhea | Dietary Supplement: low calcium milk of 180 ml Dietary Supplement: regular milk of 180 ml Dietary Supplement: regular milk of 180 ml + probiotics | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 494 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 Start Date : | August 2007 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1 |
Dietary Supplement: low calcium milk of 180 ml
twice daily for 24 weeks |
Active Comparator: 2 |
Dietary Supplement: regular milk of 180 ml
twice daily for 24 weeks |
Active Comparator: 3 |
Dietary Supplement: regular milk of 180 ml + probiotics
twice daily for 24 weeks |
Active Comparator: 4 |
Dietary Supplement: regular milk of 180 ml + probiotics
twice daily for 24 weeks |
- The mean number of episodes and duration of acute diarrheal disease [ Time Frame: 24 weeks ]
- Incidence of acute diarrheal disease [ Time Frame: 24 weeks ]
- Severity of acute diarrheal disease [ Time Frame: 24 weeks ]
- Intestinal and systemic inflammation [ Time Frame: 24 weeks ]
- Intestinal colonization with pathogenic bacteria or viruses [ Time Frame: 24 weeks ]
- Nutritional status based on anthropometric measurement [ Time Frame: 24 weeks ]
- Iron and zinc status [ Time Frame: 24 weeks ]
- Incidence, mean episodes and duration of acute respiratory infections [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 1 Year to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512824
Indonesia | |
Seameo-Tropmed Rccn Ui | |
Jakarta, Indonesia, 10430 |
Principal Investigator: | Rina Agustina, MD | SEAMEO-TROPMED RCCN UI | |
Study Chair: | Frans J. Kok, Prof | Division of Human Nutrition, Wageningen University (WUR) | |
Study Director: | Ingeborg Bovee-Oudenhoven, PhD | TIFN/ NIZO Food Research | |
Study Chair: | Agus Firmansyah, Prof, MD | Faculty of Medicine University of Indonesia | |
Study Director: | Widjaja Lukito, MD | SEAMEO-TROPMED RCCN UI |
Responsible Party: | Ingeborg Bovee-Oudenhoven, Top Institute Food and Nutrition |
ClinicalTrials.gov Identifier: | NCT00512824 |
Other Study ID Numbers: |
A011-CPDI |
First Posted: | August 8, 2007 Key Record Dates |
Last Update Posted: | January 10, 2011 |
Last Verified: | January 2011 |
calcium probiotics diarrhea children |
Indonesia Healthy children acute diarrhea |
Diarrhea Signs and Symptoms, Digestive Calcium Carbonate Calcium Calcium-Regulating Hormones and Agents |
Physiological Effects of Drugs Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |