The Effects of a Multi-vitamin Supplement in Adult Females

Completed · Not applicable · Has a placebo group

Conditions studied: Health, Subjective

In brief

The investigators are examining how the daily consumption of a multi-vitamin/mineral supplement affects the following variables in 21-40 year old women: 1. blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays) 2. blood cell gene expression patterns (assessed from blood draws and real-time PCR assays) 3. mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.

Key facts

Study ID: NCT03828097
Run by: Auburn University
People needed: 94
Starts: 2018-05-01
Expected to finish: 2019-06-01
Last updated by the study team: 2020-09-28

Who can join

Age: 21 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Subjects must be healthy adult women (21-40 years)
Subjects must possess a body mass index between 20-30 kg/m2
Subjects can be of all demographics, race, and skin types
Subjects must have a regular menstrual cycle
Subjects must have never have smoked tobacco
Subjects 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).
Subjects must be able to travel to test site on scheduled dates/times without transportation issues.

You may not qualify if…

Any prescribed medication except for oral contraceptives (not acceptable if oral contraceptives are used to disrupt normal/monthly menstrual cycle) - includes recent antibiotic and/or oral corticosteroid use
Medical history including 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 (Crohn's, pancreatitis, ulcerative colitis), multiple sclerosis, muscular dystrophy, asthma/COPD
Anyone incapable of adhering to the study protocol or knowing likelihood of moving away from the study site
Known allergies to algal oils, high-oleic sunflower oil, coconuts/coconut oil
Pregnant (or become pregnant during the course of the study)
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
Consumers of alcohol, > 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
Dietary practices: more than one fish meal per week, or daily consumption of more than a Tablespoon of flaxseeds
Caffeine-containing beverages are allowable if not excessive (more than the equivalent of 6 cups of coffee daily) and if they do not contain added vitamins; energy drinks or energy capsules containing caffeine are allowable if they have been used routinely
Dietary Supplements: those taking multivitamin-mineral (MVM), prenatal vitamins, B vitamins, fish oil, krill oil, flaxseed oil dietary supplements. Meal replacement drinks or powders with 100% or more of the Daily Values for vitamins and minerals are also excluded, but if subjects cease their use they can be admitted into the study.
Allowable supplements include calcium with or without Vitamin D (if the Vitamin D does not exceed 400 IU daily), fiber supplements not exceeding recommended doses on product labels, melatonin, niacin, herbal supplements without added vitamins, glucosamine/chondroitin, sports supplements, drinks or powders that do not contain vitamins and minerals (for example: protein powders, creatine, electrolytes, nitric oxide enhancers). Other supplements can be considered on a case-by-case basis.
Study subjects must not be in active litigation regarding malpractice, workman's compensation, or disability claims.
Study subjects must not be employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study.

Where it is running

School of Kinesiology, Auburn University — Auburn, Alabama, United States

Full record on ClinicalTrials.gov

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