HealthyNCT00512824
Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children
A study testing low calcium milk of 180 ml, regular milk of 180 ml and regular milk of 180 ml + probiotics in people with Healthy and Diarrhea, run by Wageningen University at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- What is being tested?
- low calcium milk of 180 ml, regular milk of 180 ml and regular milk of 180 ml + probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 494 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Seameo-Tropmed Rccn Ui
Jakarta, Jakarta Special Capital Region, 10430
About this study
Official title: Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children Aged 1-6 Years in Low Socio-economic Urban Area of East Jakarta
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.
- Being tested
- low calcium milk of 180 ml, regular milk of 180 ml, regular milk of 180 ml + probiotics
- Keywords
- calcium, probiotics, diarrhea, children, Indonesia, Healthy children, acute diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low calcium milk of 180 mlDietary supplement
twice daily for 24 weeks
regular milk of 180 mlDietary supplement
twice daily for 24 weeks
regular milk of 180 ml + probioticsDietary supplement
twice daily for 24 weeks
regular milk of 180 ml + probioticsDietary supplement
twice daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Dietary Supplement: low calcium milk of 180 ml |
| 2 | Active comparator | Not described Receives: Dietary Supplement: regular milk of 180 ml |
| 3 | Active comparator | Not described Receives: Dietary Supplement: regular milk of 180 ml + probiotics |
| 4 | Active comparator | Not described Receives: Dietary Supplement: regular milk of 180 ml + probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean number of episodes and duration of acute diarrheal disease
Measured: 24 weeks
Secondary outcomes (7)
Incidence of acute diarrheal disease
Measured: 24 weeks
Severity of acute diarrheal disease
Measured: 24 weeks
Intestinal and systemic inflammation
Measured: 24 weeks
Intestinal colonization with pathogenic bacteria or viruses
Measured: 24 weeks
Nutritional status based on anthropometric measurement
Measured: 24 weeks
Iron and zinc status
Measured: 24 weeks
Incidence, mean episodes and duration of acute respiratory infections
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition, SEAMEO-TROPMED RCCN University of Indonesia
- Investigators
- Rina Agustina, MD, Principal investigator, SEAMEO-TROPMED RCCN UIFrans J. Kok, Prof, Study chair, Division of Human Nutrition, Wageningen University (WUR)Ingeborg Bovee-Oudenhoven, PhD, Study director, TIFN/ NIZO Food ResearchAgus Firmansyah, Prof, MD, Study chair, Faculty of Medicine University of IndonesiaWidjaja Lukito, MD, Study director, SEAMEO-TROPMED RCCN UI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512824
- Sponsor's protocol ID
- A011-CPDI
- Status last verified
- Jan 2011
- First submitted
- 6 Aug 2007
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Agustina R, Bovee-Oudenhoven IM, Lukito W, Fahmida U, van de Rest O, Zimmermann MB, Firmansyah A, Wulanti R, Albers R, van den Heuvel EG, Kok FJ. Probiotics Lactobacillus reuteri DSM 17938 and Lactobacillus casei CRL 431 modestly increase growth, but not iron and zinc status, among Indonesian children aged 1-6 years. J Nutr. 2013 Jul;143(7):1184-93. doi: 10.3945/jn.112.166397. Epub 2013 May 22.
PubMed 23700339Agustina 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. doi: 10.1542/peds.2011-1379. Epub 2012 Apr 9.
PubMed 22492764
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children Aged 1-6 Years in Low Socio-economic Urban Area of East Jakarta
- ClinicalTrials.gov ID
- NCT00512824
- Acronym / sponsor ID
- A011-CPDI
- Keywords
- calcium, probiotics, diarrhea, children, Indonesia, Healthy children, acute diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition, SEAMEO-TROPMED RCCN University of Indonesia
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: low calcium milk of 180 ml |
| 2 | Active comparator | Dietary Supplement: regular milk of 180 ml |
| 3 | Active comparator | Dietary Supplement: regular milk of 180 ml + probiotics |
| 4 | Active comparator | Dietary Supplement: regular milk of 180 ml + probiotics |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low calcium milk of 180 mltwice daily for 24 weeks | Dietary supplement | 1 |
| regular milk of 180 mltwice daily for 24 weeks | Dietary supplement | 2 |
| regular milk of 180 ml + probioticstwice daily for 24 weeks | Dietary supplement | 3 |
| regular milk of 180 ml + probioticstwice daily for 24 weeks | Dietary supplement | 4 |
Primary outcome
The mean number of episodes and duration of acute diarrheal disease
Time frame: 24 weeks
7 secondary outcomes
Incidence of acute diarrheal disease
Time frame: 24 weeks
Severity of acute diarrheal disease
Time frame: 24 weeks
Intestinal and systemic inflammation
Time frame: 24 weeks
Intestinal colonization with pathogenic bacteria or viruses
Time frame: 24 weeks
Nutritional status based on anthropometric measurement
Time frame: 24 weeks
Iron and zinc status
Time frame: 24 weeks
Incidence, mean episodes and duration of acute respiratory infections
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
- Derived from this study: PubMed 23700339Agustina R, Bovee-Oudenhoven IM, Lukito W, Fahmida U, van de Rest O, Zimmermann MB, Firmansyah A, Wulanti R, Albers R, van den Heuvel EG, Kok FJ. Probiotics Lactobacillus reuteri DSM 17938 and Lactobacillus casei CRL 431 modestly increase growth, but not iron and zinc status, among Indonesian children aged 1-6 years. J Nutr. 2013 Jul;143(7):1184-93. doi: 10.3945/jn.112.166397. Epub 2013 May 22.
- Derived from this study: PubMed 22492764Agustina 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. doi: 10.1542/peds.2011-1379. Epub 2012 Apr 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rina Agustina, MD principal investigator
SEAMEO-TROPMED RCCN UI
Frans J. Kok, Prof study chair
Division of Human Nutrition, Wageningen University (WUR)
Ingeborg Bovee-Oudenhoven, PhD study director
TIFN/ NIZO Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low calcium milk of 180 ml, regular milk of 180 ml and regular milk of 180 ml + probiotics in people with Healthy and Diarrhea, run by Wageningen University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean number of episodes and duration of acute diarrheal disease (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00512824, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.