Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

• ClinicalTrials.gov Identifier: NCT00512824
• Recruitment Status: Completed
• First Posted: August 8, 2007
• Last Update Posted: January 10, 2011
• Sponsor: Wageningen University
• Collaborators: Top Institute Food and Nutrition; SEAMEO-TROPMED RCCN University of Indonesia
• Information provided by: Wageningen University

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Agustina R, Bovee-Oudenhoven IM, Lukito W, Fahmida U, van de Rest O, Zimmermann MB, Firmansyah A, Wulanti R, Albers R, van den Heuvel EG, Kok FJ. Probiotics Lactobacillus reuteri DSM 17938 and Lactobacillus casei CRL 431 modestly increase growth, but not iron and zinc status, among Indonesian children aged 1-6 years. J Nutr. 2013 Jul;143(7):1184-93. doi: 10.3945/jn.112.166397. Epub 2013 May 22.

Agustina R, Kok FJ, van de Rest O, Fahmida U, Firmansyah A, Lukito W, Feskens EJ, van den Heuvel EG, Albers R, Bovee-Oudenhoven IM. Randomized trial of probiotics and calcium on diarrhea and respiratory tract infections in Indonesian children. Pediatrics. 2012 May;129(5):e1155-64. doi: 10.1542/peds.2011-1379. Epub 2012 Apr 9.

• 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
• 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; Calcium Carbonate; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents