Health, SubjectiveMVSNCT03828097
The Effects of a Multi-vitamin Supplement in Adult Females
A study testing Experimental supplement in people with Health, Subjective, run by Auburn University at 1 site in United States.
Trial 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. blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays) 2. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- Experimental supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Kinesiology, Auburn University
Auburn, Alabama, 36849
About this study
Official title: The Effects of a Multi-vitamin Supplement on Mood and Blood Markers in Adult Females Prior to and Following 12 Weeks of Supplementation
The investigators are examining how the daily consumption of a multi-vitamin/mineral supplement affects the following variables in 21-40 year old women:
- blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays)
- blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)
- mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.
Read the detailed description
The investigators are testing the efficacy of a multi-vitamin/mineral/omega-3 complex on psychological and physiological measures in pre-menopausal women (21-40 years old) over a 12-week period.
This study will be a double-blinded, placebo-controlled intervention. Briefly, subjects will be screened for inclusion criteria. Eligible subjects will then undergo a pre-testing battery (i.e., T1) and will then be randomly assigned to one of two groups including:
- Experimental group (anticipated n=50)
- Control group (anticipated n=50) Subjects will then consume 2 capsules per day for 12 weeks and perform a post-testing battery (i.e., T2) that includes tests performed during the pre-testing battery.
Main outcome (dependent) variables between treatments will include:
- blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays)
- blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)
- mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.
Statistics used to assess differences between conditions over time will include two-way repeated measures ANOVAs. When significant group*time interactions are observed, the statistical model will be decomposed using LSD post hoc tests.
- Conditions
- Health, Subjective
- Being tested
- Experimental supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental supplementDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Experimental supplement |
| Placebo | Placebo comparator | Participants in this arm will receive two capsules per day containing safflower oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (3)
Blood red blood cell concentrations
Whole blood will be collected at PRE and POST-intervention and assessed using a CBC test. The CBC test provides red concentration. Results from these tests will be compared to reference range values for apparently healthy female individuals.
Measured: 12 weeks
White blood cell concentrations
Whole blood will be collected at PRE and POST-intervention and assessed using a CBC test. The CBC test also provides white blood cell concentration. Results from these tests will be compared to reference range values for apparently healthy female individuals.
Measured: 12 weeks
Serum cholesterol concentrations
Whole blood will be collected at PRE and POST-intervention, and serum will be extracted and assessed using a chem-20 test. The chem-20 test provides serum lipid concentrations (i.e., LDL cholesterol, HDL cholesterol). Results from these tests will be compared to reference range values for apparently healthy female individuals.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 May 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Roberts, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828097
- Sponsor's protocol ID
- 18-092 MR 1803
- Acronym
- MVS
- Status last verified
- Sep 2020
- First submitted
- 28 Jan 2019
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34327207
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Multi-vitamin Supplement on Mood and Blood Markers in Adult Females Prior to and Following 12 Weeks of Supplementation
- ClinicalTrials.gov ID
- NCT03828097
- Acronym / sponsor ID
- MVS / 18-092 MR 1803
- Conditions
- Health, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are examining how the daily consumption of a multi-vitamin/mineral supplement affects the following variables in 21-40 year old women:
- blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays)
- blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)
- mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.
Detailed description
The investigators are testing the efficacy of a multi-vitamin/mineral/omega-3 complex on psychological and physiological measures in pre-menopausal women (21-40 years old) over a 12-week period.
This study will be a double-blinded, placebo-controlled intervention. Briefly, subjects will be screened for inclusion criteria. Eligible subjects will then undergo a pre-testing battery (i.e., T1) and will then be randomly assigned to one of two groups including:
- Experimental group (anticipated n=50)
- Control group (anticipated n=50) Subjects will then consume 2 capsules per day for 12 weeks and perform a post-testing battery (i.e., T2) that includes tests performed during the pre-testing battery.
Main outcome (dependent) variables between treatments will include:
- blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays)
- blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)
- mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.
Statistics used to assess differences between conditions over time will include two-way repeated measures ANOVAs. When significant group*time interactions are observed, the statistical model will be decomposed using LSD post hoc tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blinded, parallel
| Arm | Type | Receives |
|---|---|---|
| Experimental supplement | Experimental | Dietary Supplement: Experimental supplementParticipants 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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive two capsules per day containing safflower oil |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental supplementSubjects 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. | Dietary supplement | Experimental supplement |
| PlaceboSubjects 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. | Dietary supplement | Placebo |
Primary outcome
Serum concentrations of micronutrients
Time frame: 12 weeks
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.
Red blood cell omega-3 and omega-6 concentrations
Time frame: 12 weeks
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.
3 secondary outcomes
Blood red blood cell concentrations
Time frame: 12 weeks
White blood cell concentrations
Time frame: 12 weeks
Serum cholesterol concentrations
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Derived from this study: PubMed 34327207Osburn 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental supplement in people with Health, Subjective, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentrations of micronutrients (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.