Vitamin D Replacement in Insulin Resistant South Asians

• Register: ClinicalTrials.gov
• Last refreshed on: 11 February 2013
• Main ID: NCT01385345
• Date of registration: 14/06/2011
• Primary sponsor: University of Leicester
• Public title: Vitamin D Replacement in Insulin Resistant South Asians VITALITY
• Scientific title: Can Vitamin D Replacement Reduce Insulin Resistance In South Asians With Vitamin D Deficiency?
• Date of first enrolment: August 2012
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01385345
• 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

Countries of recruitment

United Kingdom

Contacts

• Name: Melanie J Davies, MD

• Name: Samiul A Mostafa, MBChB

• Name: Melanie J Davies, MD
• Affiliation: University of Leicester

Key inclusion & exclusion 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.



Age minimum: 25 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Insulin Resistance

Vitamin D Deficiency

Intervention(s)

Drug: Vitamin D3 cholecalciferol

Primary Outcome(s)

HOMA2-IR (homeostatic model assessment of insulin resistance) [Time Frame: 6 months]

Secondary Outcome(s)

fasting plasma glucose [Time Frame: 6 months]

HbA1c [Time Frame: 6 months]

Tolerability of high dose Vitamin D3 treatment regime [Time Frame: 6 months]

two hour plasma glucose [Time Frame: 6 months]

Secondary ID(s)

RM61G0293

Source(s) of Monetary Support

Please refer to primary and secondary sponsors