Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512824
• Other study ID #: A011-CPDI
• Status: Completed
• Phase: N/A
• First received: August 6, 2007
• Last updated: January 7, 2011
• Start date: August 2007
• Est. completion date: September 2008

Study information

• Verified date: January 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Healthy

Intervention

Dietary Supplement:
• low calcium milk of 180 ml
twice daily for 24 weeks
• regular milk of 180 ml
twice daily for 24 weeks
• regular milk of 180 ml + probiotics
twice daily for 24 weeks
• regular milk of 180 ml + probiotics
twice daily for 24 weeks

Locations

Country	Name	City	State
Indonesia	Seameo-Tropmed Rccn Ui	Jakarta

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Indonesia University, Top Institute Food and Nutrition

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean number of episodes and duration of acute diarrheal disease		24 weeks	No
Secondary	Incidence of acute diarrheal disease		24 weeks	No
Secondary	Severity of acute diarrheal disease		24 weeks	No
Secondary	Intestinal and systemic inflammation		24 weeks	No
Secondary	Intestinal colonization with pathogenic bacteria or viruses		24 weeks	No
Secondary	Nutritional status based on anthropometric measurement		24 weeks	No
Secondary	Iron and zinc status		24 weeks	No
Secondary	Incidence, mean episodes and duration of acute respiratory infections		24 weeks	No