A Trial to Study the Effect of Long Term Vitamin D Supplementation on Insulin Sensitivity (LongtermVitD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Sitaram Bhartia Institute of Science and Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research
ClinicalTrials.gov Identifier:
NCT01052181
First received: January 16, 2010
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Insulin Resistance
Drug: Cholecalciferol
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Control Trial to Study the Effect of Long Term Vitamin D Supplementation on Peripheral Insulin Sensitivity in Apparently Healthy Middle Aged Centrally Obese Adults

Resource links provided by NLM:


Further study details as provided by Sitaram Bhartia Institute of Science and Research:

Primary Outcome Measures:
  • INsulin Sensitivity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • symptoms of toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D supplementation
Cholecalciferol sachets 120,000 IU monthly for 12 months
Drug: Cholecalciferol
Oral Cholecalciferol sachets 120,000 IU monthly for 1 year
Other Name: Calcirol
Placebo Comparator: placebo
placebo with same taste, color, odor
Drug: placebo
2 sachets monthly for an year

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 35 to 75 years of age
  2. Waist circumference (WC) ≥78 cm in men and ≥ 72 cm in women

Exclusion Criteria:

  1. Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication
  2. Resting Blood Pressure>140/90 mmHg or on anti-hypertensive medication
  3. Receiving/received Vitamin D or calcium supplementation in the previous 6 months
  4. Chronic disease-renal/hepatic/malignancy/gastrointestinal
  5. On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
  6. Febrile illness or infective morbidity in the past 10 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052181

Locations
India
Sitaram Bhartia Institute of Science and Research
New Delhi, Delhi, India, 110016
Sponsors and Collaborators
Dr Jitender Nagpal
Indian Council of Medical Research
Investigators
Principal Investigator: Jitender Nagpal, MD Sitaram Bhartia Institute of Science and Research
  More Information

Publications:
Responsible Party: Dr Jitender Nagpal, PI, Sitaram Bhartia Institute of Science and Research
ClinicalTrials.gov Identifier: NCT01052181     History of Changes
Other Study ID Numbers: SBISR/2010/01
Study First Received: January 16, 2010
Last Updated: June 5, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by Sitaram Bhartia Institute of Science and Research:
Vitamin D
Insulin sensitivity
Centrally obese

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Cholecalciferol
Ergocalciferols
Insulin
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Hypoglycemic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014