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| Name | Class |
|---|---|
| Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia | OTHER_GOV |
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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.
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
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.
Secondary Objectives:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Probiotics and Vitamin D |
|
| Control Group | Placebo Comparator | Placebo and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics, Vitamin D | Dietary Supplement | Combination of two supplement that given separately |
|
| Measure | Description | Time Frame |
|---|---|---|
| Zonulin level | To investigate the changes of Zonulin level during intervention | Baseline and endline (3 month) |
| Vitamin D level | To investigate the changes of Vitamin D level during intervention | Baseline and endline (3 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status | Measurement of nutritional status using Body Mass Index (BMI) and waist circumference | Baseline and endline (3 month) |
| Gut microbiota (optional) | Measurement of gut microbiota in fecal using Next Generation Sequencing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rina Agustina, MD, PhD | HNRC-IMERI, Faculty of Medicine Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wisma Emergency COVID-19 Hospital (RSDC) | Jakarta | DKI Jakarta | 10640 | Indonesia | ||
| Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14585636 | Background | Zhong NS, Zheng BJ, Li YM, Poon, Xie ZH, Chan KH, Li PH, Tan SY, Chang Q, Xie JP, Liu XQ, Xu J, Li DX, Yuen KY, Peiris, Guan Y. Epidemiology and cause of severe acute respiratory syndrome (SARS) in Guangdong, People's Republic of China, in February, 2003. Lancet. 2003 Oct 25;362(9393):1353-8. doi: 10.1016/s0140-6736(03)14630-2. | |
| 32257431 |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D000086382 | COVID-19 |
| D050177 | Overweight |
| D009765 | Obesity |
| D007153 | Immunologic Deficiency Syndromes |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Independent party masked the intervention and control product
| Placebo | Other | Placebo with inactive ingredient |
|
| Baseline and endline (3 month) |
| Inflammation marker | Measurement of inflammation markers IL-6, IL-10 TNF-α using ELISA | Screening |
| Cathelicidin level | Measurement of cathelicidin using ELISA | Screening |
| SARS COV-2 | Measurement of quantitative antibody | Screening |
| CD4/CD8 ratio | Measurement of CD4/CD8 ratio using flowcytometry | Screening |
| Covid-19 infection | 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. | Baseline and endline (3 month) |
| Jakarta Pusat |
| DKI Jakarta |
| 10430 |
| Indonesia |
| Dr.Cipto Mangunkusumo General Hospital (RSCM) | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
| University of Indonesia Hospital (RSUI) | Depok | West Java | 16424 | Indonesia |
| Shereen MA, Khan S, Kazmi A, Bashir N, Siddique R. COVID-19 infection: Origin, transmission, and characteristics of human coronaviruses. J Adv Res. 2020 Mar 16;24:91-98. doi: 10.1016/j.jare.2020.03.005. eCollection 2020 Jul. |
| 32320270 | Background | Sattar N, McInnes IB, McMurray JJV. Obesity Is a Risk Factor for Severe COVID-19 Infection: Multiple Potential Mechanisms. Circulation. 2020 Jul 7;142(1):4-6. doi: 10.1161/CIRCULATIONAHA.120.047659. Epub 2020 Apr 22. No abstract available. |
| 32380044 | Background | Kass DA, Duggal P, Cingolani O. Obesity could shift severe COVID-19 disease to younger ages. Lancet. 2020 May 16;395(10236):1544-1545. doi: 10.1016/S0140-6736(20)31024-2. Epub 2020 May 4. No abstract available. |
| 30250849 | Background | Nagpal R, Newman TM, Wang S, Jain S, Lovato JF, Yadav H. Obesity-Linked Gut Microbiome Dysbiosis Associated with Derangements in Gut Permeability and Intestinal Cellular Homeostasis Independent of Diet. J Diabetes Res. 2018 Sep 3;2018:3462092. doi: 10.1155/2018/3462092. eCollection 2018. |
| 32340216 | Background | Calder PC, Carr AC, Gombart AF, Eggersdorfer M. Optimal Nutritional Status for a Well-Functioning Immune System Is an Important Factor to Protect against Viral Infections. Nutrients. 2020 Apr 23;12(4):1181. doi: 10.3390/nu12041181. |
| 31426423 | Background | Childs CE, Calder PC, Miles EA. Diet and Immune Function. Nutrients. 2019 Aug 16;11(8):1933. doi: 10.3390/nu11081933. |
| 32215956 | Background | Wong SH, Lui RN, Sung JJ. Covid-19 and the digestive system. J Gastroenterol Hepatol. 2020 May;35(5):744-748. doi: 10.1111/jgh.15047. Epub 2020 Apr 19. |
| 24780623 | Background | King S, Glanville J, Sanders ME, Fitzgerald A, Varley D. Effectiveness of probiotics on the duration of illness in healthy children and adults who develop common acute respiratory infectious conditions: a systematic review and meta-analysis. Br J Nutr. 2014 Jul 14;112(1):41-54. doi: 10.1017/S0007114514000075. Epub 2014 Apr 29. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
| D019602 |
| Food and Beverages |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |