ADHDPhase 1NCT03103750

Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD

A Phase 1 study testing Magnetic Resonance Imaging (MRI), PHNO and calcitriol in people with ADHD, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Specific Aim 1: As part of a within-subject, two-days, study design, to determine whether acute calcitriol (vs. placebo) pre-treatment is associated with greater amphetamine (Amp)-induced dopamine (DA) release in the caudate, putamen, ventral striatum (VST), and substantia nigra / ventral tegmental area (SN/VTA) of… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: ADHD
What is being tested?: Magnetic Resonance Imaging (MRI), PHNO and calcitriol
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2017to 17 Jan 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-50 years
Voluntary, written, informed consent
Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
For females, non-lactating, with a negative serum or urine pregnancy test
Lab results without clinically relevant findings (e.g. renal function, electrolytes, and vitamin D levels)
English speaking

Who cannot join

Medical contraindication to Dexedrine administration (e.g., history of cardiac problems, seizures, glaucoma, hypertension, hyperthyroidism, etc.)
Medical contraindication to calcitriol administration (e.g., history of hypersensitivity to calcitriol or any component of the formulation, hypercalcemia or vitamin D toxicity)
History of substance dependence (e.g., alcohol, opiates, sedative hypnotics), except for nicotine
A primary major DSM-5 psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-5 (SCID)
A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular accidents, seizure, traumatic brain injury) illness
Positive answers on the cardiac history questionnaire that may place the subject at higher risk, as determined by an internal medicine specialist or cardiologist's review of both the questionnaire responses and screening ECG

Show all 24Show fewer

Current use of psychotropic and/or potentially psychoactive prescription medications
For females, laboratory (β-HCG) or physical evidence of pregnancy/lactation 9) MRI-incompatible implants and other contraindications for MRI (i.e., aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker)
History of claustrophobia or feeling of inability to lie still on his/her back for the PET or MRI scans
History of any bleeding disorder or current anticoagulant therapy
Donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first test day.
Use of any prescription medications and/or over-the-counter medications, vitamins and/or herbal supplements which could have a negative clinical interaction with calcitriol/Dexedrine or which could confound scientific results of the study, within 2 weeks prior to each test day (e.g., thiazide diuretics, Mg based antiacids, digoxin, etc,.).
Serum levels of 25(OH)D3 below 20 ng/ml.
Obesity i.e. BMI over 30 (more prone to lower vitamin D levels)
Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over Radioactive Drug Research Committee (RDRC) limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
Subjects with current, past or anticipated exposure to radiation in the work place
History of kidney stones within the past 5 years
Any degree of renal failure
History of parathyroid disorder (hyper or hypoparathyroidism)
History of osteoporosis or any pathologic fractures
Vitamin D supplementation in any form in the past 3 months
Known hypersensitivity to Dexedrine, [11C]PHNO, or calcitriol
Malabsorption syndromes (i.e. Celiac sprue)
Serum corrected calcium > 10.5 mg/dl or phosphate > 4.2 mg/dl

Trial locations and contacts

1 site in 1 country.

United States1 site

Connecticut Mental Health Center
New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Study of Stimulant-induced Dopamine Release Using [11C]-PHNO PET in Healthy Humans

Specific Aim 2: To determine whether acute calcitriol (vs. placebo) pre-treatment is associated with better performance on a test of attention (e.g., the Continuous Performance Task or CPT-IP), after treatment with amphetamine. Hypothesis: Investigators hypothesize that Subjects pre-treated with calcitriol will have faster reaction times/higher accuracy on the CPT-IP vs. subjects pre-treated with placebo, after treatment with amphetamine.

Read the detailed description

Increases in the rates of childhood ADHD over the past two decades have lead to speculation that calcitriol deficiency (e.g., secondary to the increased use of sunscreen and/or increases in sedentary, indoor lifestyles in children) plays a causal/contributory role in the etiology of ADHD. To date, evidence of a direct link is lacking. One study showed higher maternal circulating Vitamin D levels in pregnancy are associated with lower risk of developing ADHD-like symptoms in childhood. On the other hand, another study did not replicate the above association, and a prospective study using umbilical cord samples stored at the time of birth reported no difference in serum vitamin D levels between ADHD group versus healthy controls. In terms of clinical trials, one randomized double blind study among adults with ADHD reported a beneficial effect of the intervention, measured with the Conners Adult ADHR rating scale, in comparison with placebo, but the intervention included the combination of vitamin D and several other micronutrients. An analysis of moderators of a positive response to ADHD behaviors did not reveal a significant predictive effect of vitamin D.

However, recent studies provide intriguing indirect evidence of an inverse relationship between solar intensity (SI) and/or altitude (a proxy for greater sun/UV light exposure) and regional rates of ADHD. One study examined three large datasets across 49 U.S. states for 2003 and 2007, and across 9 non-U.S. countries. This study examined the prevalence of ADHD and Solar Intensity (SI) maps. They found an inverse association between solar intensity and prevalence of ADHD. Another study examined two national survey datasets. They found an inverse relationship between altitude and prevalence of ADHD. Investigators hypothesize, as suggested by Huber, that a common denominator on the above studies is the increased vitamin D levels in those exposed to a higher solar intensity, which is known to increase with altitude.

Conditions: ADHD
Being tested: Magnetic Resonance Imaging (MRI), PHNO, calcitriol, Placebo oral capsule, high-resolution research tomography
Keywords: Vitamin D
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnetic Resonance Imaging (MRI)Procedure or surgery
Magnetic resonance imaging (MRI) scans (3 T) will be collected in each subject for the purposes of excluding participants with anatomical abnormalities and anatomically co-registering PET and MRI for image analysis
PHNODrug
Used as a tracer for in vivo imaging.
calcitriolDietary supplement
three 0.5 mcg capsules
Placebo oral capsuleDrug
three 0.5 mcg capsules
high-resolution research tomographyProcedure or surgery
Also called PET scan
A functional imaging technique that is used to observe metabolic processes in the body.
Dextro AmphetamineDrug
Also called Dexedrine
Dexedrine 0.3 mg/kg, to a maximum dose of 30 mg

Study groups in NCT03103750
Study group	Role	What they receive
Calcitriol then placebo	Experimental	Healthy volunteers will receive a baseline MRI. On the night before and day of testing, subjects will receive two doses of calcitriol (3.0mcg total), followed by PHNO injection and PET Scan #1. After PET Scan #1, subjects will receive a Dexedrine dose, followed by PHNO injection and PET Scan #2. A minimum of six days later, subjects will receive two doses of placebo for the night before and day of testing, followed by a third PHNO injection and PET scan #3. After PET scan #3, subjects will receive another Dexedrine dose, followed by PHNO injection and PET scan #4. Receives: Procedure: Magnetic Resonance Imaging (MRI); Drug: PHNO; Dietary Supplement: calcitriol; Drug: Placebo oral capsule; Procedure: high-resolution research tomography; Drug: Dextro Amphetamine
Placebo then Calcitriol	Experimental	Healthy volunteers will receive a baseline MRI. On the night before and day of testing, subjects will receive two doses of placebo, followed by PHNO injection and PET Scan #1. After PET Scan #1, subjects will receive a Dexedrine dose, followed by PHNO injection and PET Scan #2. A minimum of six days later, subjects will receive two doses of calcitriol (3.0mcg total) for the night before and day of testing, followed by a third PHNO injection and PET scan #3. After PET scan #3, subjects will receive another Dexedrine dose, followed by PHNO injection and PET scan #4. Receives: Procedure: Magnetic Resonance Imaging (MRI); Drug: PHNO; Dietary Supplement: calcitriol; Drug: Placebo oral capsule; Procedure: high-resolution research tomography; Drug: Dextro Amphetamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Non-displaceable Tracer Binding Potentials
non-displaceable tracer binding potentials (BPND = VT - VREF / VREF), which are linearly proportional to the density of available D2/3 Rs, computed using a simplified reference tissue model (SRTM) utilizing the cerebellum as a reference region.
Measured: day 1
Non-displaceable Tracer Binding Potentials
non-displaceable tracer binding potentials (BPND = VT - VREF / VREF), which are linearly proportional to the density of available D2/3 Rs, computed using a simplified reference tissue model (SRTM) utilizing the cerebellum as a reference region.
Measured: day 7

Secondary outcomes (2)

Continuous Performance Task (CPT-IP)
In this computer based test, subjects are shown a random sequence of numbers (2-digit, 3-digit, and 4-digit) and are instructed to press a button as quickly and accurately as possible (with their preferred hand) when a number repeats. Subjects are instructed to withhold their response for any other sequence of numbers. The measure is presented as dprime, which is calculated: d' = z(H) - z(F), where z(H) is the z-score of the hit rate and z(F) is the z-score of the false positive rate. A z-score of 0 represents the population mean. d' is indicates better performance on the task with higher values, z(H) indicates better performance on the task with higher values due to higher hit rate, and z(F) indicates worse performance on the task with higher values due to higher false positive rates.
Measured: day 1
Continuous Performance Task (CPT-IP)
In this computer based test, subjects are shown a random sequence of numbers (2-digit, 3-digit, and 4-digit) and are instructed to press a button as quickly and accurately as possible (with their preferred hand) when a number repeats. Subjects are instructed to withhold their response for any other sequence of numbers. The measure is presented as dprime, which is calculated: d' = z(H) - z(F), where z(H) is the z-score of the hit rate and z(F) is the z-score of the false positive rate. A z-score of 0 represents the population mean. d' is indicates better performance on the task with higher values, z(H) indicates better performance on the task with higher values due to higher hit rate, and z(F) indicates worse performance on the task with higher values due to higher false positive rates.
Measured: day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201717 Jan 2023

First posted6 Apr 2017
Study start15 Aug 2017
Primary completion17 Jan 2023
Study completion17 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ADHDStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: This is a within-subject, two-day four-scan, randomized, double-blind, placebo-controlled study design.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03103750
Sponsor's protocol ID: 2000020604
Other IDs: M# 25288, 1R01AT010508-01A1
Status last verified: Feb 2024
First submitted: 30 Mar 2017
Last updated: 19 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Study of Stimulant-induced Dopamine Release Using [11C]-PHNO PET in Healthy Humans
ClinicalTrials.gov ID: NCT03103750
Acronym / sponsor ID: 2000020604
Conditions: ADHD
Keywords: Vitamin D
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Brain & Behavior Research Foundation, National Center for Complementary and Integrative Health (NCCIH)
Study start: 15 Aug 2017 (actual)
Primary completion: 17 Jan 2023 (actual)
Study completion: 17 Jan 2023 (actual)
First posted: 6 Apr 2017 (actual)
Results: Posted 19 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: This is a within-subject, two-day four-scan, randomized, double-blind, placebo-controlled study design.

Arm	Type	Receives
Calcitriol then placebo	Experimental	Procedure: Magnetic Resonance Imaging (MRI), Drug: PHNO, Dietary Supplement: calcitriol, Drug: Placebo oral capsule, Procedure: high-resolution research tomography, Drug: Dextro AmphetamineHealthy volunteers will receive a baseline MRI. On the night before and day of testing, subjects will receive two doses of calcitriol (3.0mcg total), followed by PHNO injection and PET Scan #1. After PET Scan #1, subjects will receive a Dexedrine dose, followed by PHNO injection and PET Scan #2. A minimum of six days later, subjects will receive two doses of placebo for the night before and day of testing, followed by a third PHNO injection and PET scan #3. After PET scan #3, subjects will receive another Dexedrine dose, followed by PHNO injection and PET scan #4.
Placebo then Calcitriol	Experimental	Procedure: Magnetic Resonance Imaging (MRI), Drug: PHNO, Dietary Supplement: calcitriol, Drug: Placebo oral capsule, Procedure: high-resolution research tomography, Drug: Dextro AmphetamineHealthy volunteers will receive a baseline MRI. On the night before and day of testing, subjects will receive two doses of placebo, followed by PHNO injection and PET Scan #1. After PET Scan #1, subjects will receive a Dexedrine dose, followed by PHNO injection and PET Scan #2. A minimum of six days later, subjects will receive two doses of calcitriol (3.0mcg total) for the night before and day of testing, followed by a third PHNO injection and PET scan #3. After PET scan #3, subjects will receive another Dexedrine dose, followed by PHNO injection and PET scan #4.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Age 18-50 years
Voluntary, written, informed consent
Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
For females, non-lactating, with a negative serum or urine pregnancy test
Lab results without clinically relevant findings (e.g. renal function, electrolytes, and vitamin D levels)

Key exclusion criteria (24 listed)

Medical contraindication to Dexedrine administration (e.g., history of cardiac problems, seizures, glaucoma, hypertension, hyperthyroidism, etc.)
Medical contraindication to calcitriol administration (e.g., history of hypersensitivity to calcitriol or any component of the formulation, hypercalcemia or vitamin D toxicity)
History of substance dependence (e.g., alcohol, opiates, sedative hypnotics), except for nicotine
A primary major DSM-5 psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-5 (SCID)
A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular accidents, seizure, traumatic brain injury) illness

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
Magnetic Resonance Imaging (MRI)Magnetic resonance imaging (MRI) scans (3 T) will be collected in each subject for the purposes of excluding participants with anatomical abnormalities and anatomically co-registering PET and MRI for image analysis	Procedure or surgery	Calcitriol then placebo, Placebo then Calcitriol
PHNOUsed as a tracer for in vivo imaging.	Drug	Calcitriol then placebo, Placebo then Calcitriol
calcitriolthree 0.5 mcg capsules	Dietary supplement	Calcitriol then placebo, Placebo then Calcitriol
Placebo oral capsulethree 0.5 mcg capsules	Drug	Calcitriol then placebo, Placebo then Calcitriol
high-resolution research tomographyAlso: PET scanA functional imaging technique that is used to observe metabolic processes in the body.	Procedure or surgery	Calcitriol then placebo, Placebo then Calcitriol
Dextro AmphetamineAlso: DexedrineDexedrine 0.3 mg/kg, to a maximum dose of 30 mg	Drug	Calcitriol then placebo, Placebo then Calcitriol

Primary outcome

Non-displaceable Tracer Binding Potentials
Time frame: day 1
non-displaceable tracer binding potentials (BPND = VT - VREF / VREF), which are linearly proportional to the density of available D2/3 Rs, computed using a simplified reference tissue model (SRTM) utilizing the cerebellum as a reference region.
Non-displaceable Tracer Binding Potentials
Time frame: day 7
non-displaceable tracer binding potentials (BPND = VT - VREF / VREF), which are linearly proportional to the density of available D2/3 Rs, computed using a simplified reference tissue model (SRTM) utilizing the cerebellum as a reference region.

2 secondary outcomes

Continuous Performance Task (CPT-IP)
Time frame: day 1
Continuous Performance Task (CPT-IP)
Time frame: day 7

Results and safety

Results posted to the registry on 19 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Calcitriol Then Placebo	12	8
Placebo Then Calcitriol	12	10

Primary outcome: Non-displaceable Tracer Binding Potentials

Time frame: day 1. Mean (Standard Deviation). Unit: ratio

Measure	Calcitriol n = 8	Placebo n = 10
Region of interest: Ventral Striatum	2.93 (0.63)	2.91 (0.32)
Region of interest: Caudate	1.50 (0.30)	1.50 (0.19)
Region of interest: Putamen	2.21 (0.47)	2.21 (0.26)
Region of interest: Substantia Nigra/Ventral Tegmental Area	0.92 (0.30)	1.01 (0.24)

Population analysed: Participants required complete imaging data (i.e., 4/4 completed PET scans and a completed MRI) in order to be included in analysis. Thus, only n = 18 participants were analyzed to assess BPND.

Primary outcome: Non-displaceable Tracer Binding Potentials

Time frame: day 7. Mean (Standard Deviation). Unit: ratio

Measure	Calcitriol n = 10	Placebo n = 8
Region of interest: Ventral Striatum	2.91 (0.32)	3.05 (0.66)
Region of interest: Caudate	1.52 (0.21)	1.59 (0.30)
Region of interest: Putamen	2.31 (0.28)	2.38 (0.47)
Region of interest: Substantia Nigra/Ventral Tegmental Area	1.08 (0.25)	1.07 (0.31)

Calcitriol vs Placebo: p = 0.016, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Calcitriol Then Placebo	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Placebo Then Calcitriol	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Marc Potenza, PhD, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Magnetic Resonance Imaging (MRI), PHNO and calcitriol in people with ADHD, run by Yale 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 6 inclusion and 24 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 19 Mar 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Non-displaceable Tracer Binding Potentials (time frame: day 1). 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 NCT03103750.

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 19 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.