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

NCT04046289 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 238

Last updated 2019-08-07

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Low Calcium Milk

50 mg calcium/day

DIETARY_SUPPLEMENT

Regular Calcium Milk

400 mg/day

DIETARY_SUPPLEMENT

Probiotic 1

regular calcium milk + probiotic

DIETARY_SUPPLEMENT

Probiotic 2

regular calcium milk + probiotic

Sponsors & Collaborators

  • SEAMEO Regional Centre for Food and Nutrition

    collaborator OTHER

  • Wageningen University

    collaborator OTHER

  • Indonesia University

    lead OTHER

Principal Investigators

  • Rina Agustina, PhD · HNRC IMERI; Department of Nutrition, Faculty of Medicine, Universitas Indonesia

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-26
Primary Completion
2019-03-03
Completion
2019-07-05

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046289 on ClinicalTrials.gov