Immune-Mitochondrial Correction in Military Recruits

NCT07622147 | Not Yet Recruiting

• 1 other identifier: 4
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if a new immune-mitochondrial correction strategy works better than standard vitamins to prevent infections in young male military recruits during their first 6 months of service. The main questions it aims to answer are:

• Control group (100 participants): Standard multivitamin taken once a day for 30 days
• Experimental group (100 participants): New strategy (sodium nucleinate, magnesium, vitamin B6, and vitamin D 5000 IU) taken as 3 tablets once a day for 30 days to see if the new strategy lowers infection rates more than standard vitamins. Who can take part: Healthy male military recruits aged 18-27 years who are starting their initial training at the Military Clinical Hospital in Almaty, Kazakhstan. What participants will do: Participants will be placed into one of the two groups by chance (like flipping a coin). They will:
• Take study pills once a day for 30 days
• Have blood draws 3 times over 6 months (baseline, 1 month, and 6 months)
• Have daily health checks by medical staff
• Complete quality of life questionnaires What we will measure:
• Number of participants who get infections during 6 months
• How well the mitochondria in immune cells work (from blood samples)
• Immune system status
• Stress and adaptation levels
• Vitamin D and other blood markers Risks and benefits: The risks are very low. Participants may have mild discomfort or a small bruise from blood draws. All study pills are approved and registered in Kazakhstan. There is no direct benefit to participants, but they will receive extra medical monitoring. The indirect benefit is helping develop a better prevention program to protect future recruits. Where the study is taking place: Military Clinical Hospital of the Ministry of Defense of the Republic of Kazakhstan, Almaty, Kazakhstan. Study duration: January 2027 to December 2028.

Conditions

Respiratory Tract Infections (RTI); Meningitis; Primary Prevention/Methods; Primary Prevention; Mitochondrial Biomarkers; Immuno-monitoring; Immuno-modulation

Keywords

Military recruits; Infection prevention; Immunocorrection; Mitochondrial function; Sodium nucleinate; Vitamin D; Respiratory infections; Stress adaptation; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Incidence of respiratory tract infections

  Number of participants with at least one documented respiratory tract infection (ARVI, pneumonia, or meningitis) during the 6-month follow-up period. Infections are confirmed by medical examination and recorded in medical records.

  6 months

• Change in mitochondrial function of granulocytes

  Change in mitochondrial membrane potential (ΔΨm) and mitochondrial reactive oxygen species (mitoROS) in peripheral blood granulocytes measured by fluorescence microscopy using JC-1, TMRM, and MitoSOX probes according to Patent for Utility Model No. 6180.

  baseline, 1 month, 6 months

Secondary Outcomes (5)

• Change in immune status (CD4/CD8 ratio)

  baseline, 1 month, 6 months

• Change in quality of life (WHO SF-36 score)

  baseline, 6 months

• Change in stress-adaptation status (Bayevsky stress index)

  baseline, 1 month, 6 months

• Change in serum vitamin D level

  baseline, 1 month, 6 months

• Change in serum cortisol level

  baseline, 1 month, 6 months

Study Arms (2)

Standard multivitamin

ACTIVE COMPARATOR

Participants receive standard multivitamin (Vitamin A 800 mcg, Vitamin D3 200 IU, Vitamin E 10 mg, Vitamin C 60 mg, Vitamin B1 1.4 mg, Vitamin B2 1.6 mg, Vitamin B6 2 mg, Vitamin B12 1 mcg, nicotinamide 18 mg, pantothenic acid 6 mg, folic acid 200 mcg). Dosage: 1 tablet orally once daily in the morning for 30 days.

Dietary Supplement: Multivitamin/Mineral supplements

Immune-mitochondrial correction

EXPERIMENTAL

Participants receive a combination of sodium nucleinate 12 mg, magnesium citrate 400 mg, pyridoxine hydrochloride 6 mg, and vitamin D 5000 IU. Dosage: 3 tablets orally once daily in the morning for 30 days.

Dietary Supplement: Sodium nucleinate combination

Interventions

Multivitamin/Mineral supplements DIETARY_SUPPLEMENT

Standard multivitamin containing Vitamin A 800 mcg, Vitamin D3 200 IU (5 mcg), Vitamin E 10 mg, Vitamin C 60 mg, Vitamin B1 1.4 mg, Vitamin B2 1.6 mg, Vitamin B6 2 mg, Vitamin B12 1 mcg, nicotinamide 18 mg, pantothenic acid 6 mg, folic acid 200 mcg. One tablet orally once daily in the morning for 30 days.

Standard multivitamin

Sodium nucleinate combination DIETARY_SUPPLEMENT

Fixed-dose combination of sodium nucleinate 12 mg, magnesium citrate 400 mg, pyridoxine hydrochloride 6 mg, and vitamin D 5000 IU. Three tablets orally once daily in the morning for 30 days.

Immune-mitochondrial correction

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male military recruits aged 18-27 years
• Starting initial military training at the Military Clinical Hospital of the Ministry of Defense of the Republic of Kazakhstan (Almaty)
• Signed informed consent
• No acute infectious diseases at enrollment
• Willingness to comply with the study protocol for 6 months

You may not qualify if:

• Chronic immunodeficiency states (HIV infection, congenital immunodeficiencies, current immunosuppressive therapy)
• Severe chronic diseases in decompensation stage (diabetes mellitus, renal failure, hepatic failure, heart failure)
• Allergy or hypersensitivity to any components of the study interventions (multivitamin, sodium nucleinate, magnesium, vitamin B6, vitamin D)
• Use of vitamin-mineral complexes or immunomodulators within the last 3 months prior to enrollment
• Hypercalcemia (serum calcium \>2.6 mmol/L) or history of urolithiasis
• Hypermagnesemia (serum magnesium \>1.1 mmol/L)
• Sarcoidosis or other granulomatous diseases
• Refusal or inability to provide informed consent

Sponsors & Collaborators

• MIPO Clinic: lead

MeSH Terms

Conditions

Respiratory Tract Infections; Meningitis

Interventions

Geritol

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Neuroinflammatory Diseases; Nervous System Diseases

Central Study Contacts

Stanislav Panov, PhD

CONTACT

+7 747 682 6613; vramin89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to group assignment (standard multivitamin vs immuno-mitochondrial complex). Laboratory personnel performing biomarker assays and the statistician conducting the final analysis are blinded; groups labeled 'Group 1/Group 2' in the de-identified database.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, single-blind, parallel-group trial. Participants are assigned in a 1:1 ratio to either the control group (standard multivitamin for 30 days) or the experimental group (immune-mitochondrial correction: sodium nucleinate 12 mg + magnesium citrate 400 mg + pyridoxine hydrochloride 6 mg + vitamin D 5000 IU for 30 days). All participants are followed for 6 months after the intervention period to assess infectious morbidity and laboratory outcomes. The study is conducted at a single center: Military Clinical Hospital of the Ministry of Defense of the Republic of Kazakhstan (Almaty).

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share