The Effects of a Multi-vitamin Supplement in Adult Females

NCT03828097 | Completed

• 1 other identifier: 18-092 MR 1803
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays)
2. 2.blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)
3. 3.mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.

Conditions

Health, Subjective

Outcome Measures

Primary Outcomes (2)

• Serum concentrations of micronutrients

  Blood serum will be collected at PRE and POST-intervention and assessed for 25-hydroxycholecalciferol (25OHD), and folate as well as 6 associated metabolites \[folic acid, 5-methyltetrahydrofolate (5-MeTHF), 5-formyltetrahydrofolate (5-FoTHF), homocysteine (Hcy), S-adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH)\]. Overall changes in these metabolites will be compared to pre-intervention values to determine if the experimental intervention was more effective at increasing one or multiple micronutrient levels in serum.

  12 weeks

• Red blood cell omega-3 and omega-6 concentrations

  Red blood cells will be collected at PRE and POST-intervention and assayed for red blood cell omega-3 and omega-6 fatty acid content. Overall changes in these metabolites will be compared to pre-intervention values to determine if the experimental intervention was more effective at altering these fatty acid levels in red blood cells.

  12 weeks

Secondary Outcomes (3)

• Blood red blood cell concentrations

  12 weeks

• White blood cell concentrations

  12 weeks

• Serum cholesterol concentrations

  12 weeks

Study Arms (2)

Experimental supplement

EXPERIMENTAL

Participants in this arm will receive two capsules per day containing a total of 1 mg boron, 600 mcg folate, 8 mg iron, 50 mg magnesium, 320 mg omega-3 (DHA+EPA), 8 mcg vitamin B12, 50 mcg vitamin D3, and 7 mg vitamin E

Dietary Supplement: Experimental supplement

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive two capsules per day containing safflower oil

Dietary Supplement: Placebo

Interventions

Experimental supplement DIETARY_SUPPLEMENT

Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires.

Experimental supplement

Placebo DIETARY_SUPPLEMENT

Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires.

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Individuals self-identifying as females will be eligible for the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

School of Kinesiology, Auburn University

Auburn, Alabama, 36849, United States

Location

Related Publications (1)

• Osburn SC, Roberson PA, Medler JA, Shake J, Arnold RD, Alamdari N, Bucci LR, Vance A, Sharafi M, Young KC, Roberts MD. Effects of 12-Week Multivitamin and Omega-3 Supplementation on Micronutrient Levels and Red Blood Cell Fatty Acids in Pre-menopausal Women. Front Nutr. 2021 Jul 13;8:610382. doi: 10.3389/fnut.2021.610382. eCollection 2021.

  PMID: 34327207 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Pills are in white bottles with unique ID numbers (1-110). Pills are also flavor-matched (mint).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blinded, parallel

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 4, 2019
• Study Start: May 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 28, 2020

Record last verified: 2020-09

Locations

US (1)