Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

Not Applicable

Completed

• Conditions: Healthy; Diarrhea
• Interventions: Dietary Supplement: regular milk of 180 ml; Dietary Supplement: low calcium milk of 180 ml; Dietary Supplement: regular milk of 180 ml + probiotics

• Registration Number: NCT00512824
• Lead Sponsor: Wageningen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-07
• Study First Posted: 2007-08-08
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-07
• Last Update Posted: 2011-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	regular milk of 180 ml	-
1	low calcium milk of 180 ml	-
3	regular milk of 180 ml + probiotics	-
4	regular milk of 180 ml + probiotics	-

Primary Outcome Measures

Name	Time	Method
The mean number of episodes and duration of acute diarrheal disease	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seameo-Tropmed Rccn Ui; 🇮🇩 Jakarta, Indonesia