Status:
COMPLETED
Effects of Probiotics and Calcium Supplementation on Growth, Development, and Metabolic Parameters
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
SEAMEO Regional Centre for Food and Nutrition
Wageningen University
Conditions:
Stunting
Obesity
Eligibility:
All Genders
11-17 years
Brief Summary
Stunting is still a major problem in developing countries, including Indonesia, and has been associated with impaired development. Stunted children have also a higher risk of metabolic syndrome in adu...
Detailed Description
This study was a 10-year follow-up study of randomized controlled trials of 6-month probiotics and calcium supplementation of Lactobacillus reuteri DSM 17938 or Lactobacillus casei CRL 431 in children...
Eligibility Criteria
Inclusion
- Inclusion Criteria at the previous clinical trial:
- 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 six months
- Parents are willing to sign the informed consent and give the supplements to the children for six months
- Capable and willing to drink liquid milk with a straw (acceptance to be tested at the screening by providing a sample drink and placebo straw to be consumed under supervision for two days)
- Exclusion Criteria at the previous clinical trial:
- Calcium intake exceeding 75% of the Recommended Dietary Allowance (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 edema (weight-for-height 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 the 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
- Inclusion criteria of follow-up study:
- Healthy adolescent participated in the previous trial study willing to take part in the follow-up study
- Exclusion criteria of follow-up study:
- History of type 1 diabetes
- Taking the cholesterol-lowering drug, an anti-diabetic drug, or oral corticosteroid for more than 2 consecutive weeks in the last 3 months
- Pregnant
Exclusion
Key Trial Info
Start Date :
January 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 5 2019
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04046289
Start Date
January 26 2019
End Date
July 5 2019
Last Update
August 7 2019
Active Locations (1)
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1
Human Nutrition Research Center, Indonesian Medical Education Research Institute; and Department of Nutrition, Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia, 13420