ADHDPhase 1NCT04386811
Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Tele-health Study of Stimulant-induced Improvement in Neurocognitive Functioning.
A Phase 1 study testing Calcitriol in people with ADHD, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to assess vitamin D as a therapeutic adjunct in the stimulant treatment of ADHD. 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?
- Calcitriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2020to 29 Sep 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 and psychiatric history
- DSM-5 diagnosis of ADHD
- Point of Care Test results for Vitamin D equal or higher than 20 ng/ml
- English speaking
Who cannot join
- 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-V psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-V (SCID), except ADHD
- A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular accidents, seizure, traumatic brain injury) illness
- Current use of psychotropic and/or potentially psychoactive prescription medications, except prescribed stimulants
- Use of any prescription medications and/or over-the-counter medications, vitamins (including vitamin D) and/or herbal supplements which could have a negative clinical interaction with calcitriol 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,).
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- Levels of 25(OH)D3 below 20 ng/ml .
- History of kidney stones within the past 5 years
- History 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 calcitriol
- Malabsorption syndromes (i.e. Celiac sprue)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess vitamin D as a therapeutic adjunct in the stimulant treatment of ADHD.
Read the detailed description
The specific aim of this study is to determine whether acute calcitriol (vitaminD) administration (compared to placebo) enhances the neurocognitive effects of of current stimulant medications as measured by tasks of vigilance/attention, spatial working memory, and reversal learning in individuals with (attention deficit hyperactivity disorder (ADHD) using a randomized, double-blind, placebo controlled, within-subject, two-day study design.
Primary Hypothesis: It is hypothesized that calcitriol (versus placebo) administration will enhance positive neurocognitive effects of current stimulant medications in individuals with ADHD.
Secondary (Exploratory) Hypothesis: It is hypothesized that calcitriol (versus placebo) administration alone will also enhance neurocognitive performance on tasks of attention/vigilance and/or spatial working memory.
- Conditions
- ADHD
- Being tested
- Calcitriol, Placebo
- 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.
CalcitriolDrug
A total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design.
PlaceboOther
A total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design.
| Study group | Role | What they receive |
|---|---|---|
| Calcitriol | Experimental | Not described Receives: Drug: Calcitriol |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced positive neurocognitive effects on the CPT-IP
On the Continuous Performance Task (CPT-IP) subjects are shown a random sequence of different numbers and are instructed to press a button as quickly and accurately as possible upon detection of two identical pairs of numbers, and to withhold their response to any other sequence of letters. Outcomes will be measured by d prime.
Measured: Up to 5 hours
Enhanced positive neurocognitive effects on the Spatial working memory task
The spatial working memory task is a measure of working memory. As part of the task, stimuli will be projected onto the computer screen and target stimuli can be spatial locations, different visual stimuli, sound or text. Outcomes will be measured by percent correct.
Measured: Up to 5 hours
Enhanced positive neurocognitive effects on the PRLT
The Probabilistic Reversal Learning Task (PRLT) measures subjects' perseverative responding in the context of changing reward contingencies / cues. Outcomes will be measured by numbers of reversal achieved, total points, and error types.
Measured: Up to 5 hours
Secondary outcomes (5)
Enhanced positive neurocognitive effects on the CPT-IP- hits
Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors.
Measured: Up to 5 hours
Enhanced positive neurocognitive effects on the CPT-IP- false alarms
Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors.
Measured: Up to 5 hours
Enhanced positive neurocognitive effects on the CPT-IP- random errors
Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors.Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors.Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors.
Measured: Up to 5 hours
Spatial working memory task- reaction time
Enhanced positive neurocognitive effects be measured by reaction time on the spatial working memory task.
Measured: Up to 5 hours
Enhanced positive neurocognitive effects on the PRLT - win-switch / lose-stay rate
Enhanced positive neurocognitive effects on the PRLT will be measured by win-switch / lose-stay rate.
Measured: Up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start5 Aug 2020
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Why it stopped: Following Yale University resuming in-person research activities, the investigators no longer had dedicated funding for the study and were unable to secure additional funding to meet the research goals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Potenza, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386811
- Sponsor's protocol ID
- 2000028035
- Status last verified
- Feb 2024
- First submitted
- 7 May 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 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 Tele-health Study of Stimulant-induced Improvement in Neurocognitive Functioning.
- ClinicalTrials.gov ID
- NCT04386811
- Acronym / sponsor ID
- 2000028035
- Conditions
- ADHD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following Yale University resuming in-person research activities, the investigators no longer had dedicated funding for the study and were unable to secure additional funding to meet the research goals.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 13 May 2020 (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.
The purpose of this study is to assess vitamin D as a therapeutic adjunct in the stimulant treatment of ADHD.
Detailed description
The specific aim of this study is to determine whether acute calcitriol (vitaminD) administration (compared to placebo) enhances the neurocognitive effects of of current stimulant medications as measured by tasks of vigilance/attention, spatial working memory, and reversal learning in individuals with (attention deficit hyperactivity disorder (ADHD) using a randomized, double-blind, placebo controlled, within-subject, two-day study design.
Primary Hypothesis: It is hypothesized that calcitriol (versus placebo) administration will enhance positive neurocognitive effects of current stimulant medications in individuals with ADHD.
Secondary (Exploratory) Hypothesis: It is hypothesized that calcitriol (versus placebo) administration alone will also enhance neurocognitive performance on tasks of attention/vigilance and/or spatial working memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcitriol | Experimental | Drug: Calcitriol |
| Placebo | Placebo comparator | Other: Placebo |
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 and psychiatric history
- DSM-5 diagnosis of ADHD
- Point of Care Test results for Vitamin D equal or higher than 20 ng/ml
Key exclusion criteria (14 listed)
- 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-V psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-V (SCID), except ADHD
- A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular accidents, seizure, traumatic brain injury) illness
- Current use of psychotropic and/or potentially psychoactive prescription medications, except prescribed stimulants
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 |
|---|---|---|
| CalcitriolA total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design. | Drug | Calcitriol |
| PlaceboA total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design. | Other | Placebo |
Primary outcome
Enhanced positive neurocognitive effects on the CPT-IP
Time frame: Up to 5 hours
On the Continuous Performance Task (CPT-IP) subjects are shown a random sequence of different numbers and are instructed to press a button as quickly and accurately as possible upon detection of two identical pairs of numbers, and to withhold their response to any other sequence of letters. Outcomes will be measured by d prime.
Enhanced positive neurocognitive effects on the Spatial working memory task
Time frame: Up to 5 hours
The spatial working memory task is a measure of working memory. As part of the task, stimuli will be projected onto the computer screen and target stimuli can be spatial locations, different visual stimuli, sound or text. Outcomes will be measured by percent correct.
Enhanced positive neurocognitive effects on the PRLT
Time frame: Up to 5 hours
The Probabilistic Reversal Learning Task (PRLT) measures subjects' perseverative responding in the context of changing reward contingencies / cues. Outcomes will be measured by numbers of reversal achieved, total points, and error types.
5 secondary outcomes
Enhanced positive neurocognitive effects on the CPT-IP- hits
Time frame: Up to 5 hours
Enhanced positive neurocognitive effects on the CPT-IP- false alarms
Time frame: Up to 5 hours
Enhanced positive neurocognitive effects on the CPT-IP- random errors
Time frame: Up to 5 hours
Spatial working memory task- reaction time
Time frame: Up to 5 hours
Enhanced positive neurocognitive effects on the PRLT - win-switch / lose-stay rate
Time frame: Up to 5 hours
Results and safety
The study was stopped early (reason given: Following Yale University resuming in-person research activities, the investigators no longer had dedicated funding for the study and were unable to secure additional funding to meet the research goals.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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, 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 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 14 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: stopped early, as of the sponsor's last update on 7 Feb 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Following Yale University resuming in-person research activities, the investigators no longer had dedicated funding for the study and were unable to secure additional funding to meet the research goals.). Results are not available in the source record.
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?
Enhanced positive neurocognitive effects on the CPT-IP (time frame: Up to 5 hours). The study lists 3 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 7 Feb 2024.