Vitamin D for Inflammatory Bowel Diseases

Phase-Based Estimates
1
Effectiveness
1
Safety
Stanford University School of Medicine, Stanford, CA
Inflammatory Bowel Diseases+4 More
Vitamin D - Drug
Eligibility
18+
All Sexes
Eligible conditions
Inflammatory Bowel Diseases

Study Summary

This study is evaluating whether vitamin D treatment can change the expression of α4β7 on B cells in patients with inflammatory bowel disease.

See full description

Eligible Conditions

  • Inflammatory Bowel Diseases
  • Intestinal Diseases
  • Ileocolitis
  • Colitis, Ulcerative
  • Crohn Disease
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Vitamin D will improve 2 primary outcomes and 3 secondary outcomes in patients with Inflammatory Bowel Diseases. Measurement will happen over the course of Week 12.

Week 12
Decrease cohort mean fecal calprotectin or C-reactive protein (CRP) by 50%.
Decrease in disease activity index scores by 50%
Increase in serum vitamin D (25(OH)D levels by 10 ng/mL
Reduction in immunoglobulin coating of commensal gut bacteria by 20%.
Reduction in α4β7+ B cells by 20%

Trial Safety

Side Effects for

Risedronate
Back pain
12%
Arthralgia
7%
Fall
3%
Osteoarthritis
1%
Humerus fracture
1%
Lumbar vertebral fracture
1%
Femur fracture
1%
Hip fracture
1%
Abdominal sepsis
0%
Duodenitis
0%
Abdominal pain
0%
Hand fracture
0%
Endometrial cancer
0%
Lung neoplasm
0%
Acute kidney injury
0%
Asthma
0%
Pleurisy
0%
Presyncope
0%
Hydronephrosis
0%
Ureterolithiasis
0%
Diverticulum intestinal
0%
Intestinal obstruction
0%
Umbilical hernia
0%
Pyonephrosis
0%
Ankle fracture
0%
Injury
0%
Pelvic fracture
0%
Radius fracture
0%
Thoracic vertebral fracture
0%
Tendon rupture
0%
Tibia fracture
0%
Decreased appetite
0%
General physical condition abnormal
0%
Spinal column stenosis
0%
Breast cancer metastatic
0%
Breast cancer
0%
Acute myeloid leukaemia
0%
Basal cell carcinoma
0%
Hypergammaglobulinaemia benign monoclonal
0%
Papillary thyroid cancer
0%
Embolic stroke
0%
Epilepsy
0%
Tremor
0%
Spinal cord compression
0%
Vascular encephalopathy
0%
Calculus urinary
0%
Chronic respiratory failure
0%
Skin ulcer
0%
Aortic stenosis
0%
Arterial disorder
0%
Deep vein thrombosis
0%
Hypovolaemic shock
0%
Subclavian artery occlusion
0%
Coagulopathy
0%
Laryngeal cancer
0%
Intercostal neuralgia
0%
Multiple sclerosis
0%
Radiculopathy
0%
Diverticulum
0%
Escherichia pyelonephritis
0%
Foot fracture
0%
Spinal compression fracture
0%
Spinal fracture
0%
Non-small cell lung cancer
0%
Synovial cyst
0%
Device dislocation
0%
Device malfunction
0%
Nephrotic syndrome
0%
Chronic obstructive pulmonary disease
0%
Ischaemic stroke
0%
Atrial fibrillation
0%
Clavicle fracture
0%
Small intestinal obstruction
0%
Pneumonia
0%
Cholecystitis acute
0%
Ischaemic hepatitis
0%
Incisional hernia
0%
Invasive breast carcinoma
0%
Squamous cell carcinoma of skin
0%
Major depression
0%
Dysphagia
0%
Cardiac failure congestive
0%
Ileus
0%
Pancreatitis acute
0%
Peritonitis
0%
Postoperative wound infection
0%
Overdose
0%
Wrist fracture
0%
Uterine prolapse
0%
Regurgitation
0%
Vertebral foraminal stenosis
0%
Carotid artery stenosis
0%
Vascular dementia
0%
Confusional state
0%
Erysipelas
0%
Hiatus hernia
0%
Death
0%
Performance status decreased
0%
Biliary colic
0%
Scapula fracture
0%
Upper limb fracture
0%
Alcohol abuse
0%
Female genital tract fistula
0%
Aortic aneurysm
0%
Vena cava thrombosis
0%
Femoral neck fracture
0%
Periostitis
0%
Enteritis
0%
Gastrointestinal infection
0%
Urinary tract infection
0%
Carbohydrate antigen 19-9 increased
0%
Hypoglycaemia
0%
Dehydration
0%
Hyperlipidaemia
0%
Hyponatraemia
0%
Lumbar spinal stenosis
0%
Osteonecrosis
0%
Rotator cuff syndrome
0%
Cystadenocarcinoma ovary
0%
Invasive ductal breast carcinoma
0%
Ovarian cancer
0%
Squamous cell carcinoma
0%
Cerebellar ischaemia
0%
Cerebrovascular accident
0%
Hemiparesis
0%
Radicular pain
0%
Anxiety
0%
Dyspnoea
0%
Laryngospasm
0%
Lung disorder
0%
Hypertensive crisis
0%
Peripheral arterial occlusive disease
0%
Sudden cardiac death
0%
Hypertension
0%
Large intestine polyp
0%
Craniocerebral injury
0%
Angina pectoris
0%
Pancreatic cyst
0%
Cardiac valve disease
0%
Haemorrhoidal haemorrhage
0%
Clostridium difficile infection
0%
Lower respiratory tract infection
0%
Meniscus injury
0%
Multiple injuries
0%
Post procedural stroke
0%
Procedural vomiting
0%
Osteitis
0%
Rheumatoid arthritis
0%
Lung neoplasm malignant
0%
Plasma cell myeloma
0%
Sciatica
0%
Delirium
0%
Acute pulmonary oedema
0%
Haemothorax
0%
Systemic lupus erythematosus rash
0%
Granulomatosis with polyangiitis
0%
Peripheral artery occlusion
0%
Myocardial infarction
0%
Pyelonephritis acute
0%
Weight decreased
0%
Tendon disorder
0%
Breast neoplasm
0%
Syncope
0%
Kyphosis
0%
Renal impairment
0%
Transient ischaemic attack
0%
Oedema peripheral
0%
Fibula fracture
0%
Goitre
0%
Gastroenteritis viral
0%
Rib fracture
0%
Ovarian cyst
0%
Cataract
0%
Hypokalaemia
0%
Pleural effusion
0%
Oesophageal achalasia
0%
Patella fracture
0%
Subdural haematoma
0%
Blood pressure increased
0%
Chondrosarcoma
0%
Renal failure
0%
Cardiac failure
0%
Mitral valve incompetence
0%
Acute myocardial infarction
0%
Haemolytic anaemia
0%
Pernicious anaemia
0%
Atrioventricular block
0%
Coronary artery disease
0%
Cardiac arrest
0%
Microcytic anaemia
0%
Immune thrombocytopenic purpura
0%
Thrombocytopenia
0%
Supraventricular tachycardia
0%
Atrioventricular block complete
0%
Pericarditis
0%
Enterocolitis
0%
Nausea
0%
Left ventricle outflow tract obstruction
0%
Tricuspid valve incompetence
0%
Femoral hernia, obstructive
0%
Asthenia
0%
Cellulitis
0%
Gastritis erosive
0%
Gastroenteritis
0%
Contusion
0%
Diverticulitis
0%
Cervical vertebral fracture
0%
Appendicitis
0%
Sepsis
0%
Concussion
0%
Ulna fracture
0%
Subcutaneous haematoma
0%
Forearm fracture
0%
Procedural nausea
0%
Pseudarthrosis
0%
Bladder cancer
0%
Cervix carcinoma
0%
Pancreatic carcinoma metastatic
0%
Metastases to bone
0%
Cerebral artery embolism
0%
Depressed level of consciousness
0%
Pulmonary embolism
0%
Respiratory failure
0%
Hypotension
0%
Pain in extremity
0%
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01709110) in the Risedronate ARM group. Side effects include: Back pain with 12%, Arthralgia with 7%, Fall with 3%, Osteoarthritis with 1%, Humerus fracture with 1%.

Trial Design

2 Treatment Groups

Control
Vitamin D 50,000 IU PO every week

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Vitamin D is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Vitamin D 50,000 IU PO every week
Drug
Vitamin D 50,000 IU PO every week for 12 weeks
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 12 for reporting.

Who is running the study

Principal Investigator
J. G.
John Gubatan, Fellow in Gastroenterology
Stanford University

Closest Location

Stanford University School of Medicine - Stanford, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
who are hospitalized for an exacerbation of their disease Adult patients with inflammatory bowel disease who are hospitalized for an exacerbation of their disease are typically treated with systemic corticosteroids. show original
are scheduled No prior bowel resections are planned. show original
Low serum vitamin D (25(OH)D ≤ 25 ng/mL
I am not currently taking a high dose of vitamin D supplements. show original
I haven't used any antibiotics in the past 3 months. show original

Patient Q&A Section

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

Can inflammatory bowel diseases be cured?

Add answer

There is a high rate of remission with proper disease management and/or surgery in both Crohn's and ulcerative colitis. However, spontaneous remission still occurs in about 35% of patients with Crohn's disease and 30% of patients with ulcerative colitis. Long-term maintenance of a healthy nutritional and/or medical program is critical in maintaining remission in patients with Crohn's disease and ulcerative colitis.

Unverified Answer

What are common treatments for inflammatory bowel diseases?

Add answer

Patients with IBD frequently have multiple sub-specializations. Inflammatory bowel disease is very common in general practice; however, there is a poor understanding of how these diseases vary in treatment. Further education regarding treatment is needed for both GPs and patients.

Unverified Answer

What are the signs of inflammatory bowel diseases?

Add answer

Symptoms and signs can become evident when patients are symptomatic, but they tend to lessen markedly with the introduction of treatment. Many patients may show signs with disease progression and may be undiagnosed. This has important repercussions for medical management, and may explain some of the poor outcomes associated with disease progression since early detection is difficult.

Unverified Answer

What is inflammatory bowel diseases?

Add answer

The prevalence and severity of intestinal inflammation has increased since 1990. Crohn's disease and ulcerative colitis are the two major intestinal diseases of inflammatory polyps. The prevalence of inflammatory polyps has increased since 1987 and has stabilized in recent years. A new disease associated with chronic inflammation in the intestine is coeliac arteritis, an inflammatory arterial vasculopathy affecting the small and medium-sized arteries. The increasing trend in vasculitis in IBD has been attributed to the chronic inflammatory response to infectious or autoimmune factors in the gut. A novel, potentially important, and probably under-recognized cause of vasculitis in IBD is hypersensitivity to food antigens.

Unverified Answer

What causes inflammatory bowel diseases?

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The risk of developing these diseases increases with age, and environmental factors influence the likelihood. Exposure to NSAIDs has also been found to be associated with a decreased risk of developing IBD. In contrast, exposure to aspirin, a medication commonly used for the prevention of cardiovascular disease in people with IBD, does not seem to be associated with the development of either ulcerative colitis or Crohn disease.

Unverified Answer

How many people get inflammatory bowel diseases a year in the United States?

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The number of people with IBDs is increasing annually. IBDs had the highest case rates for all races, both sexes, and all age groups. There was an increasing incidence of CD and UC, especially UC.

Unverified Answer

Does vitamin d improve quality of life for those with inflammatory bowel diseases?

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The use of vitamin d in an effort to improve QOL in IBD was not demonstrated in this study. A larger prospective study with a specified time period for intervention is needed to determine if vitamin D has beneficial effects in IBD.

Unverified Answer

Is vitamin d safe for people?

Add answer

We found that, for people of low body weight, one in 4 require more vitamin D supplementation to achieve the recommended dosage range; for people of normal weight and overweight, one in 4 vitamin D deficiency. We identified the following risk factors for vitamin D deficiency: obesity, rheumatoid arthritis, history of malabsorption, older age, decreased dietary vitamin D, and vitamin D insufficiency in the mother. The incidence of vitamin D insufficiency and deficiency is high in this population. Results from a recent clinical trial suggests that clinicians should carefully consider this risk when prescribing vitamin D to a patient.

Unverified Answer

What are the common side effects of vitamin d?

Add answer

Vitamin D is a well-established remedy for autoimmune diseases. Its effects in the gastrointestinal tract are still being investigated. Data from a recent study show that vitamin D seems to decrease the risk of both the occurrence and the extension of the inflammation in a colonic biopsy sample.

Unverified Answer

Who should consider clinical trials for inflammatory bowel diseases?

Add answer

A majority of patients of Crohn's disease and ulcerative colitis that were offered clinical trials by physicians were uninvolved with the disease for which they were invited to participate in a clinical trial. Therefore, physicians may have inappropriately declined participation. Future clinical trials will need to include patients interested in these diseases.

Unverified Answer

What is the latest research for inflammatory bowel diseases?

Add answer

Clinical findings of IBD are nonspecific. The most common symptoms are irritable bowel, diarrhea, and abdominal pain. Results from a recent clinical trial can be diagnosed by the Mayo Clinic criteria. The diagnosis should be confirmed by a laboratory and radiologic investigation.

Unverified Answer

How does vitamin d work?

Add answer

As more is understood about how vitamin D works, we could soon be able to determine by which mechanism of action the benefits of vitamin D are obtained. Once we have understood that effect, we will be able to use vitamin D to treat a range of diseases.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Inflammatory Bowel Diseases by sharing your contact details with the study coordinator.