Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

This study has been completed.
Sponsor:
Collaborators:
Top Institute Food and Nutrition
SEAMEO-TROPMED RCCN University of Indonesia
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00512824
First received: August 6, 2007
Last updated: January 7, 2011
Last verified: January 2011
  Purpose

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 Intervention
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
Dietary Supplement: regular milk of 180 ml + probiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • The mean number of episodes and duration of acute diarrheal disease [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of acute diarrheal disease [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Severity of acute diarrheal disease [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Intestinal and systemic inflammation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Intestinal colonization with pathogenic bacteria or viruses [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Nutritional status based on anthropometric measurement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Iron and zinc status [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence, mean episodes and duration of acute respiratory infections [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 494
Study Start Date: August 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Wageningen University

Additional 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
Study First Received: August 6, 2007
Last Updated: January 7, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014