← Back to Search

Vitamin D for ADHD

Phase 1
Waitlist Available
Led By Marc Potenza, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-50 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 hours
Awards & highlights

Study Summary

This trial is testing if vitamin D can help improve symptoms of ADHD when used alongside stimulant medication.

Who is the study for?
Adults aged 18-50 with ADHD, who are physically healthy and not on psychoactive meds except prescribed stimulants. They must have normal Vitamin D levels and no major psychiatric disorders like schizophrenia or bipolar disorder. People with malabsorption syndromes, significant medical conditions, or a history of substance dependence (except nicotine) can't join.Check my eligibility
What is being tested?
The study is testing if adding vitamin D (Calcitriol) to standard stimulant treatment for ADHD improves brain function. Participants will either receive Calcitriol or a placebo without knowing which one they're getting in this proof-of-concept trial conducted via tele-health.See study design
What are the potential side effects?
Potential side effects from Calcitriol may include hypersensitivity reactions, high calcium levels in the blood, and possibly negative interactions with certain medications or supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enhanced positive neurocognitive effects on the CPT-IP
Enhanced positive neurocognitive effects on the PRLT
Enhanced positive neurocognitive effects on the Spatial working memory task
Secondary outcome measures
Enhanced positive neurocognitive effects on the CPT-IP- false alarms
Enhanced positive neurocognitive effects on the CPT-IP- hits
Enhanced positive neurocognitive effects on the CPT-IP- random errors
+2 more

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615
23%
Hypophospatemia
17%
Fatigue
13%
Increased hypertension
13%
Edema
13%
Diarrhea
13%
Pain
10%
Taste perversions
10%
Arthritis
10%
Dizziness
10%
Gastroenteritis
10%
Vertigo
10%
Rhinitis
10%
Bronchitis
10%
Rash
7%
Viral Infection
7%
Leg Cramps
7%
Hypercalcemia
7%
Allergic Infection
7%
Polydipsia
7%
Dehydration
7%
Urinary Tract Infection
3%
Chest Pain
3%
Sinusitis
3%
Headache
3%
General Infection
3%
Asthenia
3%
Fever
3%
Infection Fungal
3%
Conjuctivitis
3%
Syncope
3%
Depression
3%
Increased Cough
3%
Polyuria
3%
Abdominal Pain
3%
Photophobia
3%
Decreased libido
3%
Hypotension
3%
Nausea
3%
Esophageal ulcer
3%
Somnolence
3%
Back Pain
3%
Vomiting
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paricalcitol Treatment
Calcitriol Treatment
Cholecalciferol
Supplemental

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CalcitriolExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcitriol
2014
Completed Phase 4
~1510

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,665 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
250 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Marc Potenza, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

Calcitriol Clinical Trial Eligibility Overview. Trial Name: NCT04386811 — Phase 1
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Placebo, Calcitriol
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Calcitriol Highlights & Side Effects. Trial Name: NCT04386811 — Phase 1
Calcitriol 2023 Treatment Timeline for Medical Study. Trial Name: NCT04386811 — Phase 1
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT04386811 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals can participate in this clinical research?

"Affirmative. According to clinicaltrials.gov, this medical study that was first posted on August 5th 2020 is still currently enrolling participants. 24 individuals are required for the trial at one single site."

Answered by AI

Could I qualify to be part of this medical experiment?

"This clinical trial currently requires 24 participants, aged 18-50 and diagnosed with ADHD. In addition to the aforementioned criteria, individuals must also provide voluntary written consent, pass a physical health screening and psychiatric evaluation, present Point of Care Test results for Vitamin d levels equal or higher than 20 ng/ml, and be proficient in English."

Answered by AI

Does the recruitment process for this research study extend to individuals below 30 years of age?

"For this clinical trial, the minimum age for consideration is 18 and the maximum is 50. There are also separate studies available for minors (99) as well as seniors (32)."

Answered by AI

What objectives is this trial seeking to accomplish?

"The primary outcome of this experiment, which will take up to five hours, is the augmentation of positive neurocognitive effects on the CPT-IP. Secondary outcomes include a count of hits, false alarms and random errors as metrics for evaluating progress in enhancing these cognitive benefits."

Answered by AI

Is there any precedent for employing Calcitriol in clinical research?

"Currently, 7 trials related to Calcitriol are being conducted with one in Phase 3. With 72 sites across Beijing and beyond offering this medication, there is much opportunity for interested patients."

Answered by AI

What are the common therapeutic applications of Calcitriol?

"Calcitriol is generally the drug of choice for treating kidney failure, as well as hyperparathyroidism, secondary hypocalcemia, and psoriasis vulgaris."

Answered by AI

Is enrollment open for this experimental protocol?

"As indicated on clinicaltrials.gov, this medical trial is still in the recruitment phase. It was initially posted on August 5th 2020 and has been updated most recently on January 24th 2022."

Answered by AI

Is Calcitriol a safe and reliable treatment option for patients?

"Collective evidence supporting the safety of Calcitriol is relatively scant, resulting in a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
New Jersey
Other
Connecticut
How old are they?
18 - 65
What site did they apply to?
CMHC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

Ive tried Adderall concerta and ritalin and none of them work for me.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
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.
2020. "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. https://clinicaltrials.gov/ct2/show/NCT04386811.
~1 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top