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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
Sponsor:
Collaborators:
Top Institute Food and Nutrition
SEAMEO-TROPMED RCCN University of Indonesia
Information provided by:
Wageningen University

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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

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



Primary Outcome Measures :
  1. The mean number of episodes and duration of acute diarrheal disease [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Incidence of acute diarrheal disease [ Time Frame: 24 weeks ]
  2. Severity of acute diarrheal disease [ Time Frame: 24 weeks ]
  3. Intestinal and systemic inflammation [ Time Frame: 24 weeks ]
  4. Intestinal colonization with pathogenic bacteria or viruses [ Time Frame: 24 weeks ]
  5. Nutritional status based on anthropometric measurement [ Time Frame: 24 weeks ]
  6. Iron and zinc status [ Time Frame: 24 weeks ]
  7. 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
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

Information from the National Library of Medicine

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


Locations
Indonesia
Seameo-Tropmed Rccn Ui
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Wageningen University
Top Institute Food and Nutrition
SEAMEO-TROPMED RCCN University of Indonesia
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ingeborg Bovee-Oudenhoven, Top Institute Food and Nutrition
ClinicalTrials.gov Identifier: NCT00512824     History of Changes
Other Study ID Numbers: A011-CPDI
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: January 2011

Keywords provided by Wageningen University:
calcium
probiotics
diarrhea
children
Indonesia
Healthy children
acute diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Calcium, Dietary
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents