A Parallel-Group, Participant-Blinded Comparative Trial of an Immuno-Mitochondrial Correction Strategy (Sodium Nucleinate + Magnesium/Pyridoxine + Vitamin D3 5000 IU) Versus Standard Multivitamin Prophylaxis to Reduce Respiratory Infection Incidence in Male Military Recruits During the 6-Month Adaptation Period
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
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:
- Does the new strategy lower the number of recruits who get infections (like colds, flu, or pneumonia) over 6 months?
- 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.
详细描述
Study Rationale In Kazakhstan, infectious morbidity among military personnel is 4 times higher than in the civilian population, with severe cases accounting for 15-30% and mortality of 15-25% (Kasimov et al., 2019). Current prevention strategies (physical exercise, hardening, balanced nutrition, vitamin prophylaxis) have not sufficiently reduced infection rates. Stress-dependent immunosuppression during the adaptation period (4-6 weeks to 6 months) may explain this vulnerability.
Scientific Premise Stress activates the hypothalamic-pituitary-adrenal (HPA) axis, increasing cortisol levels, which suppresses cellular immunity and increases susceptibility to respiratory pathogens. Mitochondrial dysfunction in immune cells (granulocytes) further impairs phagocytosis and bacterial killing. The experimental intervention targets both neuroendocrine stress response (magnesium, vitamin D) and mitochondrial function (sodium nucleinate as an electron donor for complexes III-IV of the respiratory chain).
Study Design Details This is a prospective, randomized, single-blind, parallel-group trial. Randomization will be performed using a computer-generated random number sequence with a 1:1 allocation ratio. Allocation concealment will be achieved using sequentially numbered, opaque, sealed envelopes.
Blinding:
- Participants are blinded to group assignment (both interventions are administered as oral tablets of similar appearance)
- Laboratory personnel performing blood analyses are blinded to group assignment
- The statistician performing final data analysis will receive a de-identified database with groups labeled as "Group 1" and "Group 2"
- The principal investigator is not blinded (responsible for safety monitoring) Intervention Details
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 27 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
- •Absence of any
排除标准
- •Exclusion Criteria:
- •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
研究组 & 干预措施
Standard multivitamin
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.
干预措施: Multivitamin/Mineral supplements (Dietary Supplement)
Immune-mitochondrial correction
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.
干预措施: Sodium nucleinate combination (Dietary Supplement)