Can vitamin D replacement reduce insulin resistance in South Asians with vitamin D deficiency?

Not Applicable

• Conditions: Diabetes Research Network: obesity, prevention/screening, pre diabetes in ethnic minorities; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN18522562
• Lead Sponsor: niversity of Leicester

Brief Summary

2013 thesis in: https://lra.le.ac.uk/bitstream/2381/31395/1/2015MOSTAFASAPhD.pdf

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-20
• Study Completion: 2013-10-31
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
o secondary outcome measures