What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications, behavioral therapies, and nutritional supplements. Stimulant medications like methylphenidate can cause side effects such as insomnia, decreased appetite, weight loss, and increased heart rate. Behavioral therapies typically have minimal side effects but may involve emotional discomfort. Nutritional supplements, including Vitamin D, are generally well-tolerated, with occasional gastrointestinal issues or allergic reactions. Overall, these supplements have a reassuring safety profile with no serious adverse events reported.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, primarily focusing on stimulant medications such as methylphenidate (e.g., Ritalin, Concerta) and amphetamines (e.g., Adderall, Vyvanse). Non-stimulant medications like atomoxetine (Strattera) and alpha-2 adrenergic agonists such as guanfacine (Intuniv) and clonidine (Kapvay) are also approved. These medications primarily work by modulating neurotransmitter function, particularly dopamine and norepinephrine pathways. While vitamin D is being studied for its potential role in modulating neurotransmitter function and reducing inflammation, it is not currently FDA-approved specifically for ADHD treatment.

What other types of research exist?

Promising novel alternatives to Vitamin D for ADHD treatment in 2024 may include: 1) Omega-3 fatty acids, which have anti-inflammatory properties and can modulate neurotransmitter function. 2) Zinc and magnesium supplements, which are involved in neurotransmitter synthesis and regulation. 3) N-acetylcysteine (NAC), known for its antioxidant and anti-inflammatory effects. 4) Probiotics, which can influence the gut-brain axis and potentially modulate neurotransmitter function and inflammation.

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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

Must not have

Malabsorption syndromes (i.e. Celiac sprue)

Current use of psychotropic and/or potentially psychoactive prescription medications, except prescribed stimulants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 hours

Summary

This trial is testing if vitamin D can help ADHD medications work better. It focuses on people with ADHD and aims to see if vitamin D can improve attention and memory when taken with their usual medication. Vitamin D has been studied for its potential benefits in ADHD, with some trials showing improvements in symptoms when used alongside other treatments.

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You have a condition called malabsorption syndrome, like Celiac sprue, which affects your ability to absorb nutrients from food.

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You are currently taking medications that affect your mind or mood, except for prescribed stimulants.

Select...

You have a history of kidney failure.

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You have a history of problems with your parathyroid glands (which regulate calcium levels in your body).

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You have a history of weak bones or fractures caused by a disease.

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You have had kidney stones in the last 5 years.

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You have taken any kind of vitamin D supplement in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 hours

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Leg Cramps

Viral Infection

Hypercalcemia

Allergic Infection

Polydipsia

Dehydration

Urinary Tract Infection

Chest Pain

Sinusitis

Headache

General Infection

Asthenia

Fever

Infection Fungal

Conjuctivitis

Syncope

Depression

Increased Cough

Polyuria

Abdominal Pain

Photophobia

Decreased libido

Hypotension

Nausea

Esophageal ulcer

Somnolence

Back Pain

Vomiting

Pruritus

100%

80%

60%

40%

20%

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD include stimulant medications, behavioral therapies, and emerging treatments like antioxidants and vitamin D. Stimulant medications, such as methylphenidate and amphetamines, work by increasing the levels of neurotransmitters dopamine and norepinephrine in the brain, which helps improve attention and reduce hyperactive and impulsive behaviors. Behavioral therapies focus on modifying behavior through reinforcement techniques. Emerging treatments like antioxidants and vitamin D are being studied for their potential to modulate neurotransmitter function and reduce inflammation, which may help mitigate ADHD symptoms. These mechanisms are crucial for ADHD patients as they address the underlying neurochemical and inflammatory processes that contribute to the disorder, potentially offering more comprehensive symptom management.

Vitamin-mineral treatment improves aggression and emotional regulation in children with ADHD: a fully blinded, randomized, placebo-controlled trial.Antioxidant therapies in attention deficit hyperactivity disorder.