Can vitamin D replacement reduce insulin resistance in South Asians with vitamin D deficiency? | Not Recruiting
Can vitamin D replacement reduce insulin resistance in South Asians with vitamin D deficiency?
VITALITY
Trial Source

Health Conditions
  • Diabetes Research Network: obesity, prevention/screening, pre diabetes in ethnic minorities
Not Recruiting
Recruitment Status
ISRCTN18522562
Primary Trial ID Number
Summary
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 (45) 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).
Primary Outcome Measures
  • 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
  • No secondary outcome measures
Research Question
  • 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 (45) 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).
Design Type
Sorry, this information is not available
Ethics Approval
Leicestershire, Northamptonshire and Rutland Research Ethics Committee, 7 March 2011 ref: 11/HO406/6
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
100
Participant Inclusion 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 HOMA1IR = 1.93
Participant Exclusion Criteria
  • 1. Those who have been told by a doctor they have diabetes (Type 1 or 2).
  • 2. Those who developed new diabetes 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 elegible to reenter the study.
  • 3. HbA1c > 6.9% which is suggestive of diabetes.
  • 4. Preexisting 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/ Calcuim 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 (eGFR<60) or known history of liver problems/ disorders
  • 7. A history of known bone diseases (including osteoporosis, osteomalacia) or muscle diseases/ myopathies
  • 8. Any participant discovered to have new kidney/ liver/ bone or other health problems discovered during Screening or baseline visit. Such individuals will have approprioate follow up organsied. A raised PTH will be considered in the clinical context of ALP and Vitamin D level (i.e. may 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 barbituates) or potentially leading to other problems (bendroflumethiazide, digoxin)
  • 11. Participants unable to commit time for the entire six month study (e.g. holiday abroad, work commitments)
  • 12. Actively taking part in another interventional study (e.g. medication, lifestyle RCTs); observational and cross-sectional studies are still permitted
Interventions
We will run a 6 month randomised control trial of Vitamin D3 replacement: Intervention arm: Within each period of 6 to 8 weeks we now wish to give a higher dose on day 1 followed by a maintenance daily dose for the remainder of the period. 1. Month 0: 200,000 units stat day 1 followed by 1,000 units/ day for rest of period 2. Month 1.5 – six weeks later: 100,000 units stat day 1 followed by 1,000 units/ day for rest of period 3. Month 3 – six weeks later: same as (b) 4. Month 5 – two months later (V6): same as (2) 5. Month 6 – study exit and finish Control arm: 1,000 units a day for six months – then study exit and finish
Design Details
Sorry, this information is not available
Study Design
Prevention, interventional, randomised trial
Results Reporting
Sorry, this information is not available
Acronym
VITALITY
Scientific Title
Can vitamin D replacement reduce insulin resistance in South Asians with vitamin D deficiency? A randomised controlled trial.
Secondary Trial Identifying Number
10624
Website
Sorry, this information is not available
Study Funded By
Novo Nordisk UK Research Foundation (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
University of Leicester (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Jan 2012

Recruitment End Date

31 Oct 2013

Trial End Date

31 Oct 2013

Date added to Registry

20 Oct 2011

Last Updated

30 Jul 2012