Vitamin D replacement in South Asians at risk of Type 2 diabetes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

We will include the following people if they meet all criteria: 1. 25-75 year old south Asian (Bangladeshi, Indian, Pakistani, Sri Lankan or other South Asian country) 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 HOMA1-IR = 1.93.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 (WHO 1999 diagnostic criteria) 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 re-enter the study. 3. HbA1c = 6.5% which now diagnostic 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/ Calcuim for at least one-two 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 = CKD stage 3, 4 or 5) or known history of liver problems/ disorders. Also granulatamous conditions which may influence vitamin D and calcuim will be excluded. 7. A history of known bone diseases (e.g. osteoporosis, osteomalacia, osteopetrosis) or muscle diseases. People with a history of fractures and falls will also be excluded. 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 symptoms, 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 (anti-convulsants as as phenytoin, carbamazepine; primidone and barbituates), potentially leading to other problems (bendroflumethiazide, digoxin) or influencing hyperglycaemia/ insulin resistance (e.g. oral corticosteriods) 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 RCTs); observational and cross sectional studies are still permitted. 13. People with an allergy to nuts (as Vitamin D liquid preparations/ oil plaecbos) may contain small amounts of peanut oil.