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OpenTrials
Completed

NCT Number: NCT00512824

Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

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.

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Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seameo-Tropmed Rccn Ui

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low calcium milk of 180 ml

Dietary Supplement

twice daily for 24 weeks

regular milk of 180 ml

Dietary Supplement

twice daily for 24 weeks

regular milk of 180 ml + probiotics

Dietary Supplement

twice daily for 24 weeks

Primary outcomes

  1. The mean number of episodes and duration of acute diarrheal disease

    Time frame: 24 weeks

Secondary outcomes

  1. Incidence of acute diarrheal disease

    Time frame: 24 weeks

  2. Severity of acute diarrheal disease

    Time frame: 24 weeks

  3. Intestinal and systemic inflammation

    Time frame: 24 weeks

  4. Intestinal colonization with pathogenic bacteria or viruses

    Time frame: 24 weeks

  5. Nutritional status based on anthropometric measurement

    Time frame: 24 weeks

  6. Iron and zinc status

    Time frame: 24 weeks

  7. Incidence, mean episodes and duration of acute respiratory infections

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • SEAMEO-TROPMED RCCN University of Indonesia
  • Top Institute Food and Nutrition

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 8, 2007
Registry last updated
Jan 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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