None listed
Conditions
Interventions
Intervention1: Group A (test): Multivitamin Mineral Supplement (MVMS) Capsules.: One Capsule daily after dinner once a day for 90 days orally through mouth along with water.
Control Intervention1: Gro
Sponsors
Meyer Organics Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women of age within the range of 18 to 55 years (both inclusive);2. Body mass index (BMI) not less than 19 and not more than 35 kg per m 2 ; 3. 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; 4. Participants must have a regular menstrual cycle; 5. 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); 6. Not currently taking any MVMS or similar supplements;7. Willing to comply with trial procedures and visit schedules.
Exclusion criteria
Exclusion criteria: 1. 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; 2. Significant medical or psychiatric conditions that could interfere with trial participation as per the judgement of the investigator; 3. Known hypersensitivity to any component of the MVMS or placebo; 4. 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; 5. Pregnancy or breastfeeding; 6. 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; 7. Past or active smokers; 8. Irregular menstrual cycles or amenorrhea; 9. Donated blood within two months prior to study entry, and must not donate blood during the study duration; 10. Consumers of alcohol, more than 5 drinks of alcohol per week (one drink of alcohol was considered to be 142 mL of standard wine, 340 mL of beer, 35 mL of 80-proof liquor, or 10 mL of pure alcohol); 11.Have participated in any investigational therapeutic trial within the past 1 year that the investigator feels would influence or affect the outcome of the study; 12.Anyone incapable of adhering to the study protocol or knowing likelihood of moving away from the study site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in self-reported general health and well-being assessed by a SF-36 Health Survey.Timepoint: Screening, day 45 and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in nutrient levels of serum iron, vitamin D, Vitamin B12 and folate. 2. Changes in immune function assessed by WBC, immunoglobin (Ig) G and Ig A levels and complete blood count (CBC). 3. Changes in energy levels assessed by fatigue severity scale (FSS) score. 4. Changes in mental health assessed by Patient Health Questionnaire (PHQ-9) score. 5. Changes in mental health assessed by General Anxiety Disorder-7 (GAD-7) score. Timepoint: Screening, day 45 and day 90. | — |
Countries
India
Contacts
Public ContactVarsha Chhabria
Meyer Organics Pvt. Ltd.
Outcome results
None listed