Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children - Full Text View

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:

MedlinePlus related topics: Calcium Diarrhea

Drug Information available for: Calcium Gluconate Calcium carbonate

U.S. FDA Resources

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

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):

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. Epub 2012 Apr 9.

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
Calcium Carbonate

Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013