The Effects and Neural Mechanisms of Vitamin D and Iron-Immune Homeostasis on Inhibitory Control in Obsessive-Compulsive Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Neurometabolite Concentrations in Key Brain Regions
Study Overview
Brief Summary
This study is a randomized, open-labled, no-treatment-controlled clinical trial designed to investigate the effects of vitamin D and iron-immune homeostasis on inhibitory control and the underlying neural mechanisms in patients with obsessive-compulsive disorder (OCD). Participants will be patients with OCD who meet the study eligibility criteria.
The study's primary aim is to compare changes in glutamate and related metabolite concentrations within the anterior cingulate-thalamic circuit, inhibitory control performance, peripheral immune markers, and clinical symptoms before and after treatment with calcitriol and iron polysaccharide complex. The study will also investigate the neural-circuit mechanisms underlying inhibitory control deficits in patients with OCD and their changes following the interventions. These objectives will be addressed using resting-state Magnetic Resonance Spectroscopy(MRS), inhibitory control tasks, peripheral blood immune-marker measurements, and clinical symptom assessments.
The primary hypothesis is that inhibitory control deficits in patients with OCD are associated with dysregulated glutamatergic metabolism in the anterior cingulate-thalamic circuit. Vitamin D and iron supplementation are hypothesized to promote the balance of glutamate and related metabolites within this circuit, regulate immune homeostasis, and improve inhibitory control deficits in patients with OCD.
Detailed Description
Previous studies have provided evidence suggesting that vitamin D and iron supplementation may have beneficial effects in the treatment of obsessive-compulsive disorder (OCD); however, the underlying mechanisms remain unclear. Our preliminary findings indicate that inhibitory control deficits in OCD are associated with abnormalities in glutamate metabolism within the anterior cingulate-thalamic circuit. Further research suggests that disruptions in iron- and vitamin D-related immune homeostasis may affect glutamate metabolism and function.
Baseline data will be collected upon enrollment, including resting-state Magnetic Resonance Spectroscopy (MRS) data, performance on inhibitory control tasks, peripheral blood immune markers, and clinical symptom assessments.
The key research questions to be addressed are:
- Whether inhibitory control performance differs before and after treatment with calcitriol and iron polysaccharide complex;
- Whether resting-state glutamate levels within the anterior cingulate-thalamic circuit differ before and after treatment with calcitriol and iron polysaccharide complex;
- Whether glutamate and related metabolite levels within the anterior cingulate-thalamic circuit are associated with inhibitory control performance, peripheral blood immune markers, and clinical symptoms before and after treatment with calcitriol and iron polysaccharide complex.
After eligibility has been confirmed according to the inclusion and exclusion criteria and written informed consent has been obtained, all participants will complete a demographic and clinical information questionnaire, clinical symptom assessments, peripheral blood tests, and cognitive function tests. Participants will subsequently undergo magnetic resonance examination, including resting-state MRS performed under quiet resting conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meet the DSM-5 diagnostic criteria for obsessive-compulsive disorder (OCD);
- •Have a total score of ≥16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and a total score of <17 on the 17-item Hamilton Depression Rating Scale (HAMD-17);
- •Have a disease duration of ≥1 year and be between 14 and 50 years of age;
- •Be right-handed and have completed at least junior high school education; and
- •Fully understand the study procedures, be willing and able to participate in and complete the entire study, and provide written informed consent.
Exclusion Criteria
- •Presence of a neurological disorder or serious medical condition;
- •Pregnancy or breastfeeding;
- •A history of alcohol or substance abuse or dependence;
- •A history of seizures;
- •A diagnosis of a major psychotic disorder or bipolar disorder;
- •A diagnosis of depressive disorder;
- •Any contraindication to magnetic resonance imaging (MRI);
- •Use of iron or vitamin D supplements within the previous 6 months, or use of corticosteroids for any reason within the previous 3 months; or
- •Presence of an acute or chronic systemic disease that may affect iron or vitamin D levels, including, but not limited to, hypothyroidism, hyperthyroidism, hypoparathyroidism, hyperparathyroidism, diabetes mellitus, clinically active infection, or iron-deficiency anemia.
Arms & Interventions
Two-drugs group
The arm will use calcitriol and iron supplements
Intervention: Calcitriol and Iron Supplements (Drug)
Blank Control Group
Outcomes
Primary Outcomes
Change from Baseline in Neurometabolite Concentrations in Key Brain Regions
Time Frame: Baseline, Post-treatment (Week 12)
Change from baseline to Week 12 in the concentrations of Glutamate (Glu), Glutamate+Glutamine (Glx), and Glutathione (GSH) within two pre-specified regions of interest: the thalamus and the anterior cingulate cortex (ACC). Levels are measured in both resting and functional states using Magnetic Resonance Spectroscopy (MRS).
Change from Baseline in Inhibitory Control Performance
Time Frame: Baseline, Post-treatment (Week 12)
Change from baseline to Week 12 in inhibitory control performance, as measured by the error rate on a Go-Nogo task.
Secondary Outcomes
No secondary outcomes reported
Investigators
sunnyrong
Director
Guangdong Provincial People's Hospital