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Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

Primary Purpose

Healthy, Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
low calcium milk of 180 ml
regular milk of 180 ml
regular milk of 180 ml + probiotics
regular milk of 180 ml + probiotics
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring calcium, probiotics, diarrhea, children, Indonesia, Healthy children, acute diarrhea

Eligibility Criteria

1 Year - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seameo-Tropmed Rccn Ui

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

The mean number of episodes and duration of acute diarrheal disease

Secondary Outcome Measures

Incidence of acute diarrheal disease
Severity of acute diarrheal disease
Intestinal and systemic inflammation
Intestinal colonization with pathogenic bacteria or viruses
Nutritional status based on anthropometric measurement
Iron and zinc status
Incidence, mean episodes and duration of acute respiratory infections

Full Information

First Posted
August 6, 2007
Last Updated
January 7, 2011
Sponsor
Wageningen University
Collaborators
Top Institute Food and Nutrition, SEAMEO-TROPMED RCCN University of Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT00512824
Brief Title
Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wageningen University
Collaborators
Top Institute Food and Nutrition, SEAMEO-TROPMED RCCN University of Indonesia

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Diarrhea
Keywords
calcium, probiotics, diarrhea, children, Indonesia, Healthy children, acute diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
low calcium milk of 180 ml
Intervention Description
twice daily for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
regular milk of 180 ml
Intervention Description
twice daily for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
regular milk of 180 ml + probiotics
Intervention Description
twice daily for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
regular milk of 180 ml + probiotics
Intervention Description
twice daily for 24 weeks
Primary Outcome Measure Information:
Title
The mean number of episodes and duration of acute diarrheal disease
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Incidence of acute diarrheal disease
Time Frame
24 weeks
Title
Severity of acute diarrheal disease
Time Frame
24 weeks
Title
Intestinal and systemic inflammation
Time Frame
24 weeks
Title
Intestinal colonization with pathogenic bacteria or viruses
Time Frame
24 weeks
Title
Nutritional status based on anthropometric measurement
Time Frame
24 weeks
Title
Iron and zinc status
Time Frame
24 weeks
Title
Incidence, mean episodes and duration of acute respiratory infections
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rina Agustina, MD
Organizational Affiliation
SEAMEO-TROPMED RCCN UI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frans J. Kok, Prof
Organizational Affiliation
Division of Human Nutrition, Wageningen University (WUR)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ingeborg Bovee-Oudenhoven, PhD
Organizational Affiliation
TIFN/ NIZO Food Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Agus Firmansyah, Prof, MD
Organizational Affiliation
Faculty of Medicine University of Indonesia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Widjaja Lukito, MD
Organizational Affiliation
SEAMEO-TROPMED RCCN UI
Official's Role
Study Director
Facility Information:
Facility Name
Seameo-Tropmed Rccn Ui
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23700339
Citation
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.
Results Reference
derived
PubMed Identifier
22492764
Citation
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.
Results Reference
derived

Learn more about this trial

Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

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