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Nutrition, Immunity, and Covid-19 in Obese People (NICO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04979065
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : August 9, 2022
Sponsor:
Collaborator:
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Information provided by (Responsible Party):
Rina Agustina, Indonesia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Covid19 Overweight and Obesity Immune Deficiency Dietary Supplement: Probiotics, Vitamin D Other: Placebo Not Applicable

Detailed Description:

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

  1. Primary Objective:

    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.

    • To assess the mean changes in zonulin levels (as a parameter of gut integrity to indicate the intestinal microbiota dysbiosis)
    • To assess the mean changes in serum vitamin D levels
  2. Secondary Objectives:

    • To assess the relationship between nutritional status, inflammation and immunity with the risk of COVID-19 infection in health workers.
    • To understand the difference in the mean episodes of Covid-19 infection between treatment and placebo groups after giving probiotics and vitamin D 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Independent party will mask the product
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : July 24, 2021
Actual Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
Probiotics and Vitamin D
Dietary Supplement: Probiotics, Vitamin D
Combination of two supplement that given separately

Placebo Comparator: Control Group
Placebo and placebo
Other: Placebo
Placebo with inactive ingredient




Primary Outcome Measures :
  1. Zonulin level [ Time Frame: Baseline and endline (3 month) ]
    To investigate the changes of Zonulin level during intervention

  2. Vitamin D level [ Time Frame: Baseline and endline (3 month) ]
    To investigate the changes of Vitamin D level during intervention


Secondary Outcome Measures :
  1. Nutritional status [ Time Frame: Baseline and endline (3 month) ]
    Measurement of nutritional status using Body Mass Index (BMI) and waist circumference

  2. Gut microbiota (optional) [ Time Frame: Baseline and endline (3 month) ]
    Measurement of gut microbiota in fecal using Next Generation Sequencing

  3. Inflammation marker [ Time Frame: Screening ]
    Measurement of inflammation markers IL-6, IL-10 TNF-α using ELISA

  4. Cathelicidin level [ Time Frame: Screening ]
    Measurement of cathelicidin using ELISA

  5. SARS COV-2 [ Time Frame: Screening ]
    Measurement of quantitative antibody

  6. CD4/CD8 ratio [ Time Frame: Screening ]
    Measurement of CD4/CD8 ratio using flowcytometry

  7. Covid-19 infection [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • General doctors, specialist doctors, nurses and midwives who are in charge of handling COVID-19 patients or working in COVID-19 referral hospitals for at least the last 3 months
  • 20-65 years old
  • Willing to sign informed consent
  • Willing to follow the research to completion
  • BMI > 23 kg/m2

Exclusion Criteria:

  • Pregnant woman
  • Have a confirmed history of COVID-19 based on previous PCR examinations
  • Suffering from acute illness known from history and physical examination or chronic disease (eg diabetes, SLE, cardiovascular disease) known from history
  • Currently not on a diet program for weight loss or consuming probiotics regularly in the last 3 months as known from the anamnesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04979065


Contacts
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Contact: Rina Agustina, MD, PhD +62213912477 dr.rinaagustina@gmail.com
Contact: Yani Kurniawan, MD, MM, +62213912477

Locations
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Indonesia
Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Rina Agustina    +6221 2912477      
Contact: Yani Kurniawan    +62213912477    hnrc.imeri@gmail.com   
Principal Investigator: Rina Agustina, PhD         
Sub-Investigator: Erfi Prafiantini, MSc         
Sub-Investigator: Yani Kurniawan, MSc         
Sub-Investigator: Ari Fahrial Syam, Prof         
Sub-Investigator: Murdani Abdullah, Prof         
Sub-Investigator: Nurul Ratna Mutu Manikam, MSc         
Sub-Investigator: Davrina Rianda, MSc         
Sub-Investigator: Hanifa Hanifa, MSc         
Sub-Investigator: Natasha Dianasari Devana, dr         
Sub-Investigator: Chaula Putri Rizkia, dr         
Dr.Cipto Mangunkusumo General Hospital (RSCM) Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Unit Bedah Kirana 3rd Floor         
Wisma Emergency COVID-19 Hospital (RSDC) Recruiting
Jakarta, DKI Jakarta, Indonesia, 10640
Contact: Tri Widyanti, MSc         
University of Indonesia Hospital (RSUI) Recruiting
Depok, West Java, Indonesia, 16424
Contact: Wahyu I Wardhani, Sp.GK(K)         
Sponsors and Collaborators
Indonesia University
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Investigators
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Principal Investigator: Rina Agustina, MD, PhD HNRC-IMERI, Faculty of Medicine Universitas Indonesia
Publications:

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Responsible Party: Rina Agustina, Head of Human Nutrition Research Centre / Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04979065    
Other Study ID Numbers: NICO
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rina Agustina, Indonesia University:
Probiotics
Vitamin D
Immune status
Covid-19
Nutrition
Additional relevant MeSH terms:
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COVID-19
Vitamin D Deficiency
Immunologic Deficiency Syndromes
Overweight
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Body Weight
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Immune System Diseases
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents