Effects of Probiotics and Calcium Supplementation on Growth, Development, and Metabolic Parameters

NCT04046289 | Completed

• 1 other identifier: probiocal
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

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 adulthood. The gut microbiota, as a part of intestinal integrity, may promote intake of nutrient during childhood. Probiotics supplementation may optimize the balance of gut microbiota and further improve child growth during the window period. Furthermore, calcium could also improve child growth by increasing the resistance to intestinal infection. However, the long-term effects of gut microbiota optimization during childhood using probiotics and calcium on growth, development, and the metabolic condition has not widely studied.

Conditions

Stunting; Obesity; Cognitive Function 1, Social; Depression; Behavior; Dyslipidemias; Insulin Resistance; Permeability; Increased

Outcome Measures

Primary Outcomes (4)

• Child's linear growth the age of 11-17 years

  Height-for-age z-score based on the WHO Child Growth Standards.

  January - March 2019

• Child's height at the age of 11-17 years

  Height in meters.

  January - March 2019

• Child's weight at the age of 11-17 years

  Weight in kilograms.

  January - March 2019

• Child's nutritional status at the age of 11-17 years

  BMI-for-age z-score based on the WHO Child Growth Standards. BMI was calculated from height and weight measurement.

  January - March 2019

Secondary Outcomes (11)

• Gut integrity at the age of 11-17 years

  January - March 2019

• Cognitive function assessed using Raven's Progressive Matrices at the age of 11-17 years

  January - March 2019

• Symptoms related to depression assessed using Children Depression Inventory at the age of 11-17 years

  January - March 2019

• Behaviour assessed using Strength and Difficulties Questionnaire at the age of 11-17 years

  January - March 2019

• Serum BDNF at the age of 11-17 years

  January - March 2019

Study Arms (4)

Low Calcium

low calcium milk of 180 ml, twice daily for 24 weeks

Dietary Supplement: Low Calcium Milk

Regular Calcium

regular calcium milk of 180 ml, twice daily for 24 weeks

Dietary Supplement: Regular Calcium Milk

Probiotic 1

regular calcium milk of 180 ml + probiotic, twice daily for 24 weeks

Dietary Supplement: Probiotic 1

Probiotic 2

regular calcium milk of 180 ml + probiotic, twice daily for 24 weeks

Dietary Supplement: Probiotic 2

Interventions

Low Calcium Milk DIETARY_SUPPLEMENT

50 mg calcium/day

Low Calcium

Regular Calcium Milk DIETARY_SUPPLEMENT

400 mg/day

Regular Calcium

Probiotic 1 DIETARY_SUPPLEMENT

regular calcium milk + probiotic

Probiotic 1

Probiotic 2 DIETARY_SUPPLEMENT

regular calcium milk + probiotic

Probiotic 2

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Low-socioeconomic urban communities representing flooding and non-flooding areas of East Jakarta, Indonesia.

You may qualify if:

• 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)

You may not qualify if:

• 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
• Healthy adolescent participated in the previous trial study willing to take part in the 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

Sponsors & Collaborators

• Indonesia University: lead
• SEAMEO Regional Centre for Food and Nutrition: collaborator
• Wageningen University: collaborator

Study Sites (1)

Human Nutrition Research Center, Indonesian Medical Education Research Institute; and Department of Nutrition, Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 13420, Indonesia

Location

Related Publications (4)

• Agustina 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.

  PMID: 22492764 BACKGROUND

• 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.

  PMID: 23700339 BACKGROUND

• Agustina R, Rianda D, Setiawan EA. Relationships of Child-, Parents-, and Environment-Associated Determinants with Diet Quality, Physical Activity, and Smoking Habits Among Indonesian Urban Adolescents. Food Nutr Bull. 2022 Mar;43(1):44-55. doi: 10.1177/03795721211046145. Epub 2021 Oct 21.

  PMID: 34670443 DERIVED

• Setiawan EA, Rianda D, Kadim M, Meilianawati, Susanto F, Kok FJ, Shankar AH, Agustina R. Tenth year reenrollment randomized trial investigating the effects of childhood probiotics and calcium supplementation on height and weight at adolescence. Sci Rep. 2021 Jun 4;11(1):11860. doi: 10.1038/s41598-021-88819-y.

  PMID: 34088920 DERIVED

MeSH Terms

Conditions

Growth Disorders; Obesity; Depression; Behavior; Dyslipidemias; Insulin Resistance

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Behavioral Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Rina Agustina, PhD

  HNRC IMERI; Department of Nutrition, Faculty of Medicine, Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 6, 2019
• Study Start: January 26, 2019
• Primary Completion: March 3, 2019
• Study Completion: July 5, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

ID (1)