Probiotics, Vitamin D
Dietary SupplementCombination of two supplement that given separately
NCT Number: NCT04979065
The increased risk of transmission of COVID-19 infection causes the incidence of death in health workers to escalate. It requires further research on risk factors and intervention in health worker professionals, especially on immunity factors and nutritional status. Quality of diet and nutrition is very important to support the immune system when infected. Several probiotic strains have been shown to decrease the duration and incidence of diarrhea and respiratory infections, suggesting the Gut-Lung Axis pathway. Some probiotics also improve the balance of diversity in the composition of the gut microbiota and affect body weight in obese people. Probiotics have also been shown to improve vitamin D absorption. A combination of vitamin D and probiotics may be an alternative to reduce gut dysbiosis that will directly or indirectly reduce the risk and severity of viral infections including SARS-CoV-2.
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Notify Me20 year–65 year
All sexes
Interventional
Phase 2
Wisma Emergency COVID-19 Hospital (RSDC), Jakarta, DKI Jakarta, Indonesia
Obesity is increasing in Indonesia and is the cause of various diseases, especially in the presence of Vitamin D deficiency, a state of dysbiosis, causing an increase in the possibility of infection. Professional health workers have a high risk of COVID-19 due to high daily exposure. Based on a review conducted by Daniel et al, it was found that 7.3% of health workers at Reutters University tested positive for COVID-19. Based on data from the Indonesian Doctors Association (IDI) on July 12, 2020, it was known that 61 doctors had died. In addition, based on data from the Indonesian National Nurses Association (PPNI), 39 nurses have died during the COVID-19 pandemic. Therefore efforts to prevent the occurrence of COVID-19 infection by providing a combination of vitamin D and probiotics to modulate dysbiosis that will further reduce the risk of viral infection, especially COVID-19, needs to be investigated for its potential benefits.
Primary and secondary objectives
To investigate the effect of a combination of probiotics and vitamin D supplementation in modulating intestinal dysbiosis, and vitamin D status, in people with overweight and obesity, especially among frontline health workers.
Study Design:
This study has 2 phases Phase 1: a Cross-sectional study with 160 people Phase 2: a double-blind, randomized, placebo-controlled trial with two arms of intervention involving a total of 80 people.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Combination of two supplement that given separately
Placebo with inactive ingredient
Time frame: Baseline and endline (3 month)
To investigate the changes of Zonulin level during intervention
Time frame: Baseline and endline (3 month)
To investigate the changes of Vitamin D level during intervention
Time frame: Baseline and endline (3 month)
Measurement of nutritional status using Body Mass Index (BMI) and waist circumference
Time frame: Baseline and endline (3 month)
Measurement of gut microbiota in fecal using Next Generation Sequencing
Time frame: Screening
Measurement of inflammation markers IL-6, IL-10 TNF-α using ELISA
Time frame: Screening
Measurement of cathelicidin using ELISA
Time frame: Screening
Measurement of quantitative antibody
Time frame: Screening
Measurement of CD4/CD8 ratio using flowcytometry
Time frame: Baseline and endline (3 month)
Measurement of the reduction in risk of COVID-19 infection is seen from the difference in the average episodes between groups that were examined by PCR and/or Rapid antibody tests.
Indonesia University
Other
Effect of Probiotic and Vitamin D Supplementation in Modulating Gut Dysbiosis, Nutrition, Inflammation and Immune Status and Reduce Risk of COVID-19 in Obese People: Gut-Lung Axis Randomized Trial
Acronym: NICO
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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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