NCT01052181

Brief Summary

Type 2 diabetes is a major public health problem in India with an estimated a prevalence of approximately 4% and 12% in rural and urban areas respectively. Accumulating evidence suggests that serum cholecalciferol levels may be inversely related to the prevalence of diabetes, insulin resistance and metabolic syndrome. The trials available on the effect of Vitamin D supplementation on insulin/glucose metabolism have been conducted using small sample sizes in different subgroups document variable results (significant decrease in HbA1c concentration with insulin concentration in hemodialysis patients; insulin levels lower with oral Vitamin D in gestational diabetes; no effect of Vitamin D on serum insulin levels in post menopausal women). A double blind randomized controlled trial conducted at our institute using 3,60,000 IU of cholecalciferol over 6 weeks documented improvement in OGIS index of insulin sensitivity. We therefore, plan to study the long term effect of vitamin D supplementation on peripheral insulin sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4 obesity

Timeline
Completed

Started Jan 2010

Typical duration for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

2.4 years

First QC Date

January 16, 2010

Last Update Submit

September 2, 2019

Conditions

ObesityInsulin Resistance

Keywords

Vitamin DInsulin sensitivityCentrally obese

Outcome Measures

Primary Outcomes (1)

  • INsulin Sensitivity

    1 year

Secondary Outcomes (1)

  • symptoms of toxicity

    1 year

Study Arms (2)

Vitamin D supplementation

EXPERIMENTAL

Cholecalciferol sachets 120,000 IU monthly for 12 months

Drug: Cholecalciferol

placebo

PLACEBO COMPARATOR

placebo with same taste, color, odor

Drug: placebo

Interventions

CholecalciferolDRUG

Oral Cholecalciferol sachets 120,000 IU monthly for 1 year

Also known as: Calcirol
Vitamin D supplementation
placeboDRUG

2 sachets monthly for an year

placebo

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 75 years of age
  • Waist circumference (WC) ≥78 cm in men and ≥ 72 cm in women

You may not qualify if:

  • Diabetic- Fasting Blood Sugar \>126 mg/dl or on anti-diabetic medication
  • Resting Blood Pressure\>140/90 mmHg or on anti-hypertensive medication
  • Receiving/received Vitamin D or calcium supplementation in the previous 6 months
  • Chronic disease-renal/hepatic/malignancy/gastrointestinal
  • On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
  • Febrile illness or infective morbidity in the past 10 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sitaram Bhartia Institute of Science and Research

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Related Publications (1)

  • Nagpal J, Pande JN, Bhartia A. A double-blind, randomized, placebo-controlled trial of the short-term effect of vitamin D3 supplementation on insulin sensitivity in apparently healthy, middle-aged, centrally obese men. Diabet Med. 2009 Jan;26(1):19-27. doi: 10.1111/j.1464-5491.2008.02636.x.

    PMID: 19125756RESULT

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Jitender Nagpal, MD

    Sitaram Bhartia Institute of Science and Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 16, 2010

First Posted

January 20, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

IN(1)