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Comparison of effect of oral nano vitamin D3 versus placebo to reduce disease activity in patients suffering from ulcerative colitis.

A double blind randomized control trial to study the effect of oral 25-hydroxy vitamin D versus placebo in addition to standard therapy in patients with active ulcerative colitis on clinical/endoscopic response and markers of mucosal inflammation.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009232
Enrollment
60
Registered
2017-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- patients suffering from active ulcerative colitis

Interventions

Intervention1: Nano solution oral Vitamin D3: Nano preparation of oral vitamin D3. 5ml of this solution which contains 60,000 I.U.will be taken orally on empty stomach once daily for 8 days only. Con

Sponsors

PostGraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients suffering from active ulcerative colitis

Exclusion criteria

Exclusion criteria: 1.Inability to obtain written informed consent 2.Pregnant or lactating women 3.Patients with life threatening, cardiac, renal or pulmonary disease. 4.Severe disease requiring hospitalization. 5. Patients already supplemented with vitamin D

Design outcomes

Primary

MeasureTime frame
i. Response is defined as reduction of at least 3 points in the disease activity index (UCDAI) from the baseline value at 4 weeks. ii. Reduction in the stool frequency by 2/day iii. Improvement in stool consistency (Bristol score) by 2 points Timepoint: 4 weeks

Secondary

MeasureTime frame
Remission 1. Remission is defined as achieving UCDAI score less than 3 at 4 weeks 2. Reduction of Fecal Calprotectin by 50 units 3. Reduction of endoscopic and histological markers of inflammation 4. Improvement in quality of lifeTimepoint: 4 weeks

Countries

India

Contacts

Public ContactRizwan Ahamed Z

PostGraduate Institute of Medical Education and Research, Chandigarh

ushadutta@gmail.com8198877022

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026