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:
1. Does the new strategy lower the number of recruits who get infections (like colds, flu, or pneumonia) over 6 months? 2. Does the new strategy improve how well the immune cells work, specifically their mitochondria (the power source inside cells)?
Researchers will compare:
* 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.
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
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
Parallel
Multivitamin/Mineral supplements
Dietary supplementStandard 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.
Sodium nucleinate combination
Dietary supplementFixed-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.
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.
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.
Change in immune status (CD4/CD8 ratio)
Change in CD4/CD8 T-cell ratio measured by flow cytometry using a 6-pair immunophenotyping panel (CD3/CD4, CD3/CD8, CD16/CD56, CD19, HLA-DR, CD45).
Change in quality of life (WHO SF-36 score)
Change in quality of life measured by the WHO Short Form-36 (SF-36) questionnaire validated in Kazakh language. Scores range from 0 to 100, with higher scores indicating better quality of life.
Change in stress-adaptation status (Bayevsky stress index)
Change in Bayevsky stress index calculated from 5-minute cardiointervalography recordings. Higher index indicates higher stress level.
Change in serum vitamin D level
Change in 25-hydroxyvitamin D (25-OH D) level measured in ng/mL by immunoassay.
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