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Clinical Trials/ISRCTN10942256
ISRCTN10942256Active, not recruitingNot Applicable

The effect of a multivitamin supplement (Vitals+) on brain function, cognition, mood, and vasomotor symptoms in a perimenopausal woman: a proof-of-concept n = 1 deep-phenotyping study

University of East Anglia0 sites1 target enrollmentStarted: January 20, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
N/a: Single Arm Study
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
45 Years to 55 Years (—)
Sex
Female

Inclusion Criteria

  • •Female aged 45–55 years
  • •Perimenopausal (as defined by NICE Menopause guidelines 2024) for at least 2 years
  • •Free from major neuropsychiatric conditions (e.g., depression), neurological conditions (e.g. multiple sclerosis), and gynaecological conditions (e.g., endometriosis)
  • •Able to provide informed consent
  • •Willing to undergo the full study protocol, including 32 clinic visits, MRI scanning, and biological sample collection

Exclusion Criteria

  • •Currently taking hormone replacement therapy (HRT)
  • •Use of any nutritional supplements within the last 3 months
  • •Consumption of more than 1 portion of oily fish per month AND red blood cell omega-3 index >6%
  • •Consumption of more than 4 portions of fruit and vegetables per day
  • •Consumption of more than 4 portions of B-vitamin fortified foods per week
  • •Contraindication to MRI (e.g. metallic implants, pacemaker, cochlear implant, severe claustrophobia)
  • •Postmenopausal (no menstrual cycle for =12 months)

Arms & Interventions

The participant receives Vitals+, a commercially available multivitamin supplement (Heights, Braincare Limited, London), at a dose of two capsules per day for 12 weeks. The supplement contains 12 vitamins (thiamine/B1, riboflavin/B2, niacin/B3, pantothenic acid/B5, B6, biotin/B7, folate/B9 as 5-MTHF, B12 as methylcobalamin, vitamin A, vitamin C, vitamin D3, and vitamin E), 5 minerals (iron, zinc, selenium, chromium, and iodine), two omega-3 fatty acids from algae oil (EPA and DHA), and bilberry extract (36% anthocyanins). The supplement is an oral capsule.

Intervention: The participant receives Vitals+, a commercially available multivitamin supplement (Heights, Braincare Limited, London), at a dose of two capsules per day for 12 weeks. The supplement contains 12 vitamins (thiamine/B1, riboflavin/B2, niacin/B3, pantothenic acid/B5, B6, biotin/B7, folate/B9 as 5-MTHF, B12 as methylcobalamin, vitamin A, vitamin C, vitamin D3, and vitamin E), 5 minerals (iron, zinc, selenium, chromium, and iodine), two omega-3 fatty acids from algae oil (EPA and DHA), and bilberry extract (36% anthocyanins). The supplement is an oral capsule.

Investigators

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