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Completed

NCT Number: NCT02579902

Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

The purpose of this study is to determine whether vitamin D3 supplementation is effective in the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to Irritable Bowel Syndrome (IBS).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ahvaz Jundishapur University of Medical Sciences

Ahvāz, Khuzestan, 15794 - 61357, Iran

About this study

This randomized double blind clinical trial will be performed on 90 patients (45 in intervention and 45 in control group) diagnosed with IBS. The intervention group will receive 50000 IU vitamin D3 and the control group will receive placebo contains edible paraffin once every 2 weeks for six months. Variables including biomarkers of inflammation and oxidative stress, serum levels of calcium and vitamin D, anthropometric indicators and blood pressure will be measured at baseline and end of the study. The investigators will use Rome III questionnaire for evaluating the clinical signs of the disease. The questionnaires will be filled out at baseline and every 2 weeks by the patients for six months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.

Exclusion criteria

  • Patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests)
  • Any other diseases of the gastrointestinal tract such as Inflammatory Bowel Disease (IBD)
  • Any kind of abdominal surgery
  • Chronic disease such as diabetes
  • Cardiovascular, hepatic
  • Kidney and severe infection
  • Pregnancy
  • Breastfeeding
  • Smoking
  • Alcohol consumption
  • Use of dietary supplements
  • Use of vitamin D and calcium supplement during the last year before the study
  • Use any medication for signs improvement during the study period.

Treatment and study plan

vitamin D3 (cholecalciferol)

Dietary Supplement

50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.

Placebo

Dietary Supplement

placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.

Primary outcomes

  1. Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency

    Time frame: up to six months

    clinical signs will be assessed by Visual Analog Scale (VAS) 0-100mm self-report questionnaire at baseline and every two weeks for six months.

  2. Symptom Severity Score

    Time frame: up to six months

    symptom severity score will be assessed by IBS-Symptom Severity Score (IBS-SSS) self-report questionnaire baseline and after six months intervention.

Secondary outcomes

  1. Dietary intake

    Time frame: up to six months

    24-Hour dietary recalls questionnaires will be used to assess dietary pattern at baseline and after 3 and 6 months intervention.

  2. Body Weight

    Time frame: up to six months

    Body Weight will be measured in kilograms at baseline and after six months intervention.

  3. Body Mass Index (BMI)

    Time frame: up to six months

    BMI is weight in kilograms divided to height in meters squared. It will be measured at baseline and after six months intervention.

  4. Waist Circumference (WC)

    Time frame: up to six months

    WC will be measured in centimeter at baseline and after six months intervention.

  5. Hip Circumference (HC)

    Time frame: up to six months

    HC will be measured in centimeter at baseline and after six months intervention.

  6. Waist to Hip Ratio (WHR)

    Time frame: up to six months

    WHR is WC divided to HC. It will be measured at baseline and after six months intervention.

  7. Blood Pressure (BP)

    Time frame: up to six months

    BP will be measured in mmHg at baseline and after six months intervention.

  8. Health-related Quality of Life

    Time frame: up to six months

    Health-Related Quality of Life will be assessed by IBS-Quality Of Life (IBS-QOL) with 34-item Short-Form (SF-34) self-report questionnaire at baseline and after six months intervention.

  9. Tumor Necrosis Factor-α (TNF-α)

    Time frame: up to six months

    Blood serum TNF-α will be assessed by enzyme-linked immunosorbent assay (ELISA) at baseline and after six months intervention.

  10. Interleukin-10 (IL-10)

    Time frame: up to six months

    Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention.

  11. Interleukin-17 (IL-17)

    Time frame: up to six months

    Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention.

  12. Malondialdehyde (MDA)

    Time frame: up to six months

    Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention.

  13. Total Antioxidant Capacity (TAC)

    Time frame: up to six months

    Blood serum TAC will be assessed by Ferric Reducing Antioxidant Power (FRAP) assay at baseline and after six months intervention.

  14. 25-hydroxy vitamin D (25(OH)D)

    Time frame: up to six months

    Blood serum 25(OH)D will be assessed by Radioimmunoassay at baseline and after six months intervention.

  15. Calcium

    Time frame: up to six months

    Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention

Sponsors and collaborators

Lead sponsor

Ahvaz Jundishapur University of Medical Sciences

Other

Registry information

Official study title

Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2015
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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