NCT04979065: NICO

Nutrition, Immunity, and Covid-19 in Obese People

Completed Phase 2 Last updated 4 June 2024

What this trial tests

Phase 2 trial testing Probiotics, Vitamin D in Vitamin D Deficiency in 93 participants. Completed in 30 December 2022.

Timeline

24 July 2021

Primary endpoint
30 April 2022

30 December 2022

Quick facts

Lead sponsor	Indonesia University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	93
Start date	24 July 2021
Primary completion	30 April 2022
Estimated completion	30 December 2022
Sites	4 locations across Indonesia

Drugs / interventions tested

• Probiotics, Vitamin D
• Placebo

Conditions studied

• Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
• Covid19 — all drugs for Covid19 →
• Overweight and Obesity — all drugs for Overweight and Obesity →
• Immune Deficiency — all drugs for Immune Deficiency →

Sponsor

Indonesia University

Who can join

Adults 20 to 65, any sex, with Vitamin D Deficiency or Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of Neutrophil Extracellular Traps in COVID-19 Progression: An Insight for Effective Treatment.
   Blanch-Ruiz MA, Ortega-Luna R, Gómez-García G, Martínez-Cuesta MÁ, et al · · 2021 · cited 17× · PMID 35052711 · DOI 10.3390/biomedicines10010031
2. COVID-19 and Gut Injury.
   Shen S, Gong M, Wang G, Dua K, et al · · 2022 · cited 12× · PMID 36297092 · DOI 10.3390/nu14204409
3. Probiotics: A gut response to the COVID-19 pandemic but what does the evidence show?
   Brahma S, Naik A, Lordan R. · · 2022 · cited 11× · PMID 36184201 · DOI 10.1016/j.clnesp.2022.08.023
4. From Microbial Ecology to Clinical Challenges: The Respiratory Microbiome's Role in Antibiotic Resistance.
   Niculescu AG, Mitache MM, Grumezescu AM, Chifiriuc MC, et al · · 2025 · cited 3× · PMID 40333133 · DOI 10.3390/pathogens14040355