Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals

NCT01170468 | Terminated Phase 3

• 1 other identifier: RAC 2101040
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established. The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.

Conditions

Type 2 Diabetes Mellitus

Keywords

Prediabetics; DM; vitamin D

Outcome Measures

Primary Outcomes (1)

• The incidence of DM

  Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.

  2 years

Secondary Outcomes (9)

• slope of fasting glucose level

  2 years

• slope of 2-hour post challenge glucose level

  2 years

• area under the curve of BP

  2 years

• area under the curve of weight

  2 years

• area under the curve of 25 OH vitamin D level

  2 years

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Vitamin D3 5000 IU daily

Drug: Vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo daily

Drug: Placebo

Interventions

Vitamin D3 DRUG

Vitamin D3 5000 IU orally, daily for 2 years

Also known as: cholecalciferol

Vitamin D3

Placebo DRUG

Placebo orally, daily for 2 years

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l
• Who consume no more than one serving of milk/day
• Do not take vitamin supplement
• Habitually have less than 10 hour of sun exposure per week
• Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes
• Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Center

Riyadh, 11211, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Muhammad M Hammami, MD, PhD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Clinical Studies & Empirical Ethics

Study Record Dates

• First Submitted: July 25, 2010
• First Posted: July 27, 2010
• Study Start: December 1, 2011
• Primary Completion: January 15, 2014
• Study Completion: January 15, 2014
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

SA (1)