Obsessive Compulsive Disorder (OCD)NCT07763977
The Effects and Neural Mechanisms of Vitamin D and Iron-Immune Homeostasis on Inhibitory Control in Obsessive-Compulsive Disorder
A study testing Calcitriol and Iron Supplements in people with Obsessive Compulsive Disorder (OCD), run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Calcitriol and Iron Supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Mental Health Center, Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510120
About this study
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.
Read the 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.
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.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Calcitriol and Iron Supplements
- Keywords
- Obsessive Compulsive Disorder(OCD), Vitamin D, Iron-Immune Homeostasis
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitriol and Iron SupplementsDrug
In addition to participants' existing medication regimens, calcitriol and iron supplements will be added.
| Study group | Role | What they receive |
|---|---|---|
| Two-drugs group | Experimental | The arm will use calcitriol and iron supplements Receives: Drug: Calcitriol and Iron Supplements |
| Blank Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline, Post-treatment (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start6 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sunnyrong, Guangdong Provincial People's Hospital
- Investigators
- Huirong Zheng, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763977
- Sponsor's protocol ID
- KY2025-1212-01
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Neural Mechanisms of Vitamin D and Iron-Immune Homeostasis on Inhibitory Control in Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT07763977
- Acronym / sponsor ID
- KY2025-1212-01
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Obsessive Compulsive Disorder(OCD), Vitamin D, Iron-Immune Homeostasis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Aug 2026 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-drugs group | Experimental | Drug: Calcitriol and Iron SupplementsThe arm will use calcitriol and iron supplements |
| Blank Control Group | No intervention | – |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| Calcitriol and Iron SupplementsIn addition to participants' existing medication regimens, calcitriol and iron supplements will be added. | Drug | Two-drugs group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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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.
Huirong Zheng, MD principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitriol and Iron Supplements in people with Obsessive Compulsive Disorder (OCD), run by Guangdong Provincial People's Hospital at 1 site in China.
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 5 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 13 Aug 2026. 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from Baseline in Neurometabolite Concentrations in Key Brain Regions (time frame: Baseline, Post-treatment (Week 12)). 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?
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 13 Aug 2026.