Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diarrhea
• Intervention / Treatment: Dietary supplement: low calcium milk of 180 ml; Dietary supplement: regular milk of 180 ml; Dietary supplement: regular milk of 180 ml + probiotics

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Seameo-Tropmed Rccn Ui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Dietary supplement: regular milk of 180 ml; twice daily for 24 weeks
Placebo Comparator: 1	Dietary supplement: low calcium 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: 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 and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: August 6, 2007
• First Submitted That Met QC Criteria: August 7, 2007
• First Posted (Estimate): August 8, 2007

Study Record Updates

• Last Update Posted (Estimate): January 10, 2011
• Last Update Submitted That Met QC Criteria: January 7, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: children; diarrhea; probiotics; Indonesia; calcium; Healthy children; acute diarrhea
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate
• Other Study ID Numbers: A011-CPDI