Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

Wageningen University

Status: Completed

Conditions: Healthy; Diarrhea

Treatments: Dietary Supplement: regular milk of 180 ml; Dietary Supplement: regular milk of 180 ml + probiotics; Dietary Supplement: low calcium milk of 180 ml

Study type: Interventional

Funder types: Other

Identifiers

NCT00512824

A011-CPDI

Details and patient eligibility

About

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.

Enrollment: 494 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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494 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Dietary Supplement: low calcium milk of 180 ml

2

Active Comparator group

Treatment:

Dietary Supplement: regular milk of 180 ml

3

Active Comparator group

Treatment:

Dietary Supplement: regular milk of 180 ml + probiotics

Dietary Supplement: regular milk of 180 ml + probiotics

4

Active Comparator group

Treatment:

Dietary Supplement: regular milk of 180 ml + probiotics

Dietary Supplement: regular milk of 180 ml + probiotics