A randomized, double blind, placebo controlled, multicenter clinical study to evaluate the effects of a Multivitamin Mineral Supplement on womens health.
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Meyer Organics Pvt. Ltd.
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Changes in self-reported general health and
概览
简要总结
Women’s health encompasses a broad spectrum of physiological and psychological
dimensions that are influenced by various nutritional factors. Given the dynamic phases in a
woman’s life, including menstruation, pregnancy, lactation, and menopause, ensuring
optimal nutrient intake is crucial. Multivitamin and mineral supplements (MVMS) have
been proposed to fill dietary gaps and support overall health and well-being. However,
empirical evidence on their specific effects on general health markers, immune function,
energy levels, and mental health in women remains limited.
This randomized, double-blind, placebo-controlled, multicenter clinical trial aims to
evaluate the efficacy and safety of an MVMS in improving general health and well-being
among women aged 18 to 55 years. The study will assess the impact on various health
markers, including nutrient levels, immune function, energy levels, and mental health.
Over a 90-day period, we will conduct assessments at screening, day 45, and day 90.
Primary and secondary endpoints will measure changes in self-reported health (SF-36
Health Survey), nutrient levels, immune function, energy levels, and mental health (PHQ-9
and GAD-7 scores). Adverse events, serious adverse events, treatment compliance, and
tolerability will be monitored throughout the study to ensure the safety of the participants.
This clinical trial will provide robust evidence on the benefits of MVMS in women’s health.
By evaluating a comprehensive range of health markers, the study aims to validate the role
of MVMS in enhancing general health, immune function, energy levels, and mental well-
being. The findings will have significant implications for nutritional recommendations and
the development of targeted health interventions for women.
Each soft gelatin capsule of MVMS contains a balanced blend of vitamins, minerals, and
essential oils, including elemental magnesium, starflower oil, evening primrose oil, vitamin
C, nicotinamide, elemental iron, and several other vital nutrients. This formulation is
designed to address common nutritional deficiencies and support overall health in women.
Therefore, a randomized, double blind, placebo controlled, multicenter clinical study is
planned to evaluate the effects of a Multivitamin Mineral Supplement on women’s health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women of age within the range of 18 to 55 years (both inclusive);
- •Body mass index (BMI) not less than 19 and not more than 35 kg per m 2 ;
- •Participants in normal physiological health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations with no chronic medical conditions;
- •Participants must have a regular menstrual cycle;
- •Participants must be willing to practice at least one of the following methods of birth control: (1)Total abstinence from sexual intercourse with someone of the opposite sex during the study duration; (2) Sexual intercourse with a vasectomized partner; (3) Contraceptive (oral, parenteral, or transdermal) for at least 3 consecutive months prior to and during the study duration; (4) Use of an intrauterine contraceptive device; (5) Other acceptable forms of birth control (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream);
- •Not currently taking any MVMS or similar supplements;
- •Willing to comply with trial procedures and visit schedules.
排除标准
- •Medical history including but not limited to the following: cardiovascular disease, cancer, coagulopathies, current anemia, epilepsy, thyroid disease, parathyroid diseases, diabetes, hepatitis, brain injuries or other brain-related diseases, depression treated with prescription medications, liver diseases, abnormal lipid metabolism, digestive disorders (Crohns, pancreatitis, ulcerative colitis), multiple sclerosis, muscular dystrophy, asthma or COPD;
- •Significant medical or psychiatric conditions that could interfere with trial participation as per the judgement of the investigator;
- •Known hypersensitivity to any component of the MVMS or placebo;
- •Participants currently taking any of the following supplements for health maintenance or benefits: multivitamin-mineral (MVM), prenatal vitamins, B vitamins, fish oil, krill oil, flaxseed oil, melatonin, niacin, Ayurvedic or herbal supplements, nutraceutical supplements, fiber supplements, glucosamine or chondroitin, sports supplements, drinks or powders containing vitamins and minerals, meal replacement drinks or powders with 100% or more of the Daily Values for vitamins and minerals, probiotics, vitamin D, calcium supplements, iron supplements, or protein powders;
- •Pregnancy or breastfeeding;
- •Any prescribed medication except for oral contraceptives (not acceptable if oral contraceptives are used to disrupt normal or monthly menstrual cycle).
- •includes recent antibiotic and or oral corticosteroid use;
- •Past or active smokers;
- •Irregular menstrual cycles or amenorrhea;
- •Donated blood within two months prior to study entry, and must not donate blood during the study duration;
结局指标
主要结局
Changes in self-reported general health and
时间窗: Screening, day 45 and day 90.
well-being assessed by a SF-36 Health Survey.
时间窗: Screening, day 45 and day 90.
次要结局
- 1. Changes in nutrient levels of serum iron,(vitamin D, Vitamin B12 and folate.)
研究者
Dr Suchitra Pandit
Surya Hospital