Vitamin D Replacement in Insulin Resistant South Asians (VITALITY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Leicester
Sponsor:
Information provided by (Responsible Party):
University of Leicester
ClinicalTrials.gov Identifier:
NCT01385345
First received: June 14, 2011
Last updated: February 6, 2013
Last verified: January 2013
  Purpose

This study will test the hypothesis that 6 months of periodic high dose Vitamin D3 replacement (200,000 and 100,000 units cholecalciferol, oral liquid drops at 6 to 8 week intervals) followed in-between by daily 1000 units, decreases insulin resistance by HOMA2-IR ≥ 0.36, in comparison to control, standard dose Vitamin D3 1000IU/ day for 6 months, in south Asians with both Vitamin D deficiency (defined as 25 Hydroxy vitamin D < 25nmol/l) and insulin resistance (defined as HOMA1 -IR≥ 1.93).

The hypothesis formed suggests that insulin resistance developed in South Asians is explained, at least in part, by the presence of Vitamin D Deficiency (VDD). Therefore if the VDD is reversed/ 'normalised into target range' using Vitamin D therapy in individuals at risk of diabetes, then markers of insulin resistance should reduce from baseline values. However, current UK recommended doses of Vitamin D do not adequately replenish severe VDD, common in South Asians, back into the target range and therefore will not reduce insulin resistance markers. Therefore only higher pharmacological doses are able to replace severe Vitamin D deficiency adequately and improve insulin resistance markers.


Condition Intervention
Vitamin D Deficiency
Insulin Resistance
Drug: Vitamin D3 cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Can Vitamin D Replacement Reduce Insulin Resistance In South Asians With Vitamin D Deficiency?

Resource links provided by NLM:


Further study details as provided by University of Leicester:

Primary Outcome Measures:
  • HOMA2-IR (homeostatic model assessment of insulin resistance) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This study will test the hypothesis that 6 months of periodic high dose Vitamin D3 replacement (200,000 and 100,000 units cholecalciferol, oral liquid drops at 6 to 8 week intervals) followed in-between by daily 1000 units, decreases insulin resistance by HOMA2-IR ≥ 0.36, in comparison to control, standard dose Vitamin D3 1000IU/ day for 6 months, in south Asians with both Vitamin D deficiency (defined as 25 Hydroxy vitamin D < 25nmol/l) and insulin resistance (defined as HOMA1 -IR≥ 1.93).


Secondary Outcome Measures:
  • fasting plasma glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    reduction in fasting plasma

  • HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • two hour plasma glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tolerability of high dose Vitamin D3 treatment regime [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    We will assess how tolerable taking the high dose Vitamin D3 treatment in terms of side effects


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D3 high dose
200,000 units (time 0) followed by (100,000 units) at months 1.5, 3 and 5. Participants will also have daily 1,000 units per day to mirror the control arm and maintain double blinding.
Drug: Vitamin D3 cholecalciferol
High dose Vitamin D3 (200,000 units followed by 100,000 units x 3 over 6 months) plus daily 1,000 units Vitamin D3 per day vs only daily 1,000 units Vitamin D3 per day
Placebo Comparator: Vitamin D3
Participants will have a placebo liquid (to mirror the active arm high dose Vitamin D3) and also have daily 1,000 units Vitamin D3.
Drug: Vitamin D3 cholecalciferol
High dose Vitamin D3 (200,000 units followed by 100,000 units x 3 over 6 months) plus daily 1,000 units Vitamin D3 per day vs only daily 1,000 units Vitamin D3 per day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

We will include the following people if they meet all criteria:

  1. 25-75 year old south Asian (Bangladeshi, Indian or Pakistani) men or women.
  2. A low vitamin D level (defined by a specific marker, 25(OH)VitD <25 nmol/L)
  3. Insulin resistance, defined as homeostatic model assessment of Insulin resistance (HOMA1-IR) ≥ 1.93.

Exclusion Criteria:

We will exclude people if they have any one of the following:

  1. Those who have been told by a doctor they have diabetes (Type 1 or 2).
  2. Those who developed new diabetes (World Health Organisation (WHO) 1999 guidelines) detected on the Screening Visit fasting glucose test (such participants will be offered a confirmatory test to determine if they have diabetes with an oral glucose tolerance test) or the oral glucose tolerance test at Baseline Visit. Any individual with new diabetes will have follow up arranged with a doctor. If the confirmatory test does not show new diabetes, the participant will is eligible to re-enter the study.
  3. HbA1c ≥ 7.0% which is suggestive of diabetes.
  4. Pre-existing calcium and/or Vitamin D tablets (D2 ergocalciferol or D3 cholecalciferol) / therapy (e.g. intramuscular injections, oral liquid preparations) or previous adverse reaction to Vitamin D (D2 or D3). Any individual who has previously been on these therapy must have been off Vitamin D/ Calcium for at least six months.
  5. Pregnancy or breast feeding females, or actively trying/ intending to become pregnant during the planned six month trial.
  6. A history of known or newly detected hypercalcaemia or hypocalcaemia, hyperparathyroidism (that induce high calcium levels), kidney stones or other kidney problems/ low kidney function (estimated glomerular filtration rate <60 = Chronic kidney disease stage 3, 4 or 5) or known history of liver problems/ disorders.
  7. A history of known bone diseases (e.g. osteoporosis, osteomalacia, osteopetrosis) or muscle diseases.
  8. Any participant discovered to have new kidney/ liver/ bone or other health problems discovered during Screening or Baseline visit. Such individuals will have appropriate follow up organised. A raised Parathyroid Hormone (PTH) will be considered in the clinical context of symptoms, Alkaline Phosphatase (ALP) and Vitamin D level (i.e. may or may not be excluded).
  9. Terminal illness, malignancy or physical inability to give consent (not language barriers).
  10. Taking medications which may interfere with Vitamin D metabolism (phenytoin, carbamazepine, primidone and barbiturates) or potentially leading to other problems (bendroflumethiazide, digoxin).
  11. Participants unable to commit time for the six month study (e.g. holiday abroad, work commitments).
  12. Actively taking part in another interventional study (e.g. medication, lifestyle Randomised controlled trials); observational and cross sectional studies are still permitted.
  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: NCT01385345

Contacts
Contact: Samiul A Mostafa, MBChB +44 1162584389 samiul.mostafa@uhl-tr.nhs.uk
Contact: David Webb, MBChB +44 116 2584389 david.webb@uhl-tr.nhs.uk

Locations
United Kingdom
Leicester Diabetes Centre, University Hospitals of Leicester Recruiting
Leicester, Leicestershire, United Kingdom, LE5 4PW
Contact: Melanie J Davies, MD    +44 116 252 6481    melanie.davies@uhl-tr.nhs.uk   
Contact: Kamlesh Khunti, PhD    +44 252 5445    kk22@le.ac.uk   
Principal Investigator: Melanie J Davies, MD         
Sponsors and Collaborators
University of Leicester
Investigators
Principal Investigator: Melanie J Davies, MD University of Leicester
  More Information

No publications provided

Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT01385345     History of Changes
Other Study ID Numbers: RM61G0293
Study First Received: June 14, 2011
Last Updated: February 6, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Leicester:
Vitamin D deficiency
Insulin resistance

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

ClinicalTrials.gov processed this record on September 30, 2014