NCT05080530

Brief Summary

The main objective of this study is to evaluate the effect of vitamin D3 on diabetic individual with painful neuropathy in a tertiary healthcare. The people with diabetes (type 1 and type 2) who have a Douleur Neuropathique 4 (DN4) score ≥4 will be considered eligible in this prospective study. Their serum samples will be subjected to pre-and post-biochemical screening of serum 25 (OH) D and HbA1c. The individual having Vitamin D insufficiency and deficiency will be administered a single dose of oral Vitamin D3 (Soft Gel capsule 200,000 IU), and follow-up for post-biochemical screening after 3 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

October 29, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

September 29, 2021

Last Update Submit

July 19, 2022

Conditions

Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in DN4 score.

    The change will be observed with the help of neuropathic pain assessment questionnaire.

    3 months

  • Change from baseline in serum HbA1c.

    The change will be observed in the serum values of glycated hemoglobin at the end point after the administration of vitamin D.

    3 months

  • Change from baseline in serum vitamin D.

    The cholecalciferol (Vitamin D) level in serum will be observed at the end point after the administration of vitamin D.

    3 months

Study Arms (4)

1. Normal Vit D (> 30ng/mL)

NO INTERVENTION

Follow-up after 3 months with standard treatment

2. Insufficient Vit D (20-30ng/mL)

EXPERIMENTAL

single oral dose capsule 200,000 IU of Cholecalciferol

Drug: Cholecalciferol

3. Insufficient Vit D (20-30ng/mL)

NO INTERVENTION

Follow-up after 3 months with standard treatment

4. Deficient Vit D

EXPERIMENTAL

single oral dose capsule 200,000 IU of Cholecalciferol

Drug: Cholecalciferol

Interventions

CholecalciferolDRUG

Effect of Vitamin D on diabetic neuropathy symptoms

Also known as: Sunny D™ (Vitamin D3) Softgel Capsule
2. Insufficient Vit D (20-30ng/mL)4. Deficient Vit D

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insulin dependent diabetes
  • Insulin independent diabetes
  • Age range between 25 to 80 years
  • Glycated hemoglobin (HbA1c) level must be ≥ 6.5%
  • Apparently no symptoms of Vitamin D Deficiency

You may not qualify if:

  • History of hyperparathyroidism
  • Pregnant women
  • Lactating mothers
  • History for rickets and osteomalacia
  • On Vitamin D supplementation
  • On Multivitamin
  • On anti-epileptics
  • On steroids
  • On bisphosphonates
  • On oral contraceptives
  • Subjects who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baqai Institute of Diabetology and Endocrinology (BIDE)

Karachi, Sindh, 74600, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Abdul Basit, Director

    Baqai Institute of Diabetology and Endocrinology (BIDE)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul Basit, Professor

CONTACT

009221-36707179research@bide.edu.pk

Asher Fawwad, Professor

CONTACT

009221-36707179asherfawwad@bide.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, and Director

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 15, 2021

Study Start

October 29, 2021

Primary Completion

August 20, 2022

Study Completion

August 20, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)