An interventional study of Calcitriol and Iron Supplements in Obsessive Compulsive Disorder (OCD), sponsored by Guangdong Provincial People's Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Treatment
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.
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:
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.
The intervention will last for three months. Follow-up assessments will be conducted at 1, 3, 6, and 12 months after completion of the intervention.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The arm will use calcitriol and iron supplements
Drug: Calcitriol and Iron Supplements
In addition to participants' existing medication regimens, calcitriol and iron supplements will be added.
Change from Baseline in Neurometabolite Concentrations in Key Brain Regions
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).
Time frame: Baseline, Post-treatment (Week 12)
Change from Baseline in Inhibitory Control Performance
Change from baseline to Week 12 in inhibitory control performance, as measured by the error rate on a Go-Nogo task.
Time frame: Baseline, Post-treatment (Week 12)
Started Aug 2024 (actual). Primary completion is estimated for Dec 2026, 28 months after the start.
Of 234 non-industry interventional studies with no phase under Obsessive-Compulsive Disorder, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 65. This study's planned 28 months is below that.
Counting every sponsor, half of 237 studies reached it within 43 months; a quarter within 22 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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Obsessive-Compulsive Disorder →
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