None listed
Conditions
Brief summary
The D4D/D4T2DM trial is designed as a multi-centre, single-blind, randomized, parallel group, superiority study to determine the role of Vitamin D from the oral supplement, sun exposure and dietary invention in controlling and reducing DM risks. The current study hypothesised that adequate vitamin D level will help with correcting blood sugar level and HbA1c. Eligible participants will be randomised in equal proportion into one of 4 groups: vitamin D supplement, dietary intervention, sun exposure and control group for duration of 9 months. This study will help to understand and explain the possible association between vitamin D and Diabetes Mellitus, help to reduce the cost of clinical care; the cost of medicine; reduce the compliance of DM and reduce the incidence of hospitalization.
Interventions
Arm1. Vitamin D supplement group – MUST take Ostelin Vitamin D3 oral supplements 500IU per day for 9 months duration.
Arm2. Dietary intake group – MUST follow the dietary plan (dietary plan including a list of vitamin D rich food using “µg vitamin D /gram food” as reference , a 3 day Vitamin D meal plan and 3 suggested cooking recipes) prescribed by Accredited Practising Dietitian (with min 5 years experiences) to obtain 10-15µg vitamin D per pay; participants are responsible for preparing the
Arm1. Vitamin D supplement group – MUST take Ostelin Vitamin D3 oral supplements 500IU per day for 9 months duration. Arm2. Dietary intake group – MUST follow the dietary plan (dietary plan including a list of vitamin D rich food using “µg vitamin D /gram food” as reference , a 3 day Vitamin D meal plan and 3 suggested cooking recipes) prescribed by Accredited Practising Dietitian (with min 5 years experiences) to obtain 10-15µg vitamin D per pay; participants are responsible for preparing the food for themselves and do not have to follow the recipes but are required to tick the vitamin D rich food list in order to reach 10-15µg vitamin D per pay and keep the record for duration of 9 months. Arm3. Sun exposure group – MUST expose about 15% of body surface (hands, face and arms) under the sun anytime from 10am to 4pm for 3-4 min/d from December to January, or 8 min/d from July to August or 10– 11 min/d from February to June or September to November in order to obtain approximately 12.5 µg/d of vitamin D; duration for 9 months. Control group - no interventions nor changes are required or provided to this group in current trial We will have a monthly check (10-30min phone call or personal visit, on 2nd, 4th,5th,6th,7th, 8th month) and a face to face interview (1 hour, on base line, 3rd and 9th month, conducted in Earlwood Medical Centre) conducted by Requested Nurse (RN) or health practitioners who received GCP training to follow up the participants and collect the data. Following sessions will delivered in both monthly phone call and face to face interview and undifferentiated to all 3 intervention groups and the control group: Information delivery session, anthropometry assessment (height, weight and BMI), data collection (dietary data via 3 day food recall using either smart phone application ‘east diet diary’ or paper base, and/or 24 hour food recall and/or food frequency questionnaire, sun exposure data via questionnaire adapted from 45 and up Questionnaire, and supplement pill count), adherence session (reminder text, phone call checking and offering plan for next stage), problem and safety session, adverse event assessment and/or blood test ( a blood test of blood glucose, HbA1c and vitamin D will be conducted only on baseline, 3rd and 9th month during face to face interview by RN).
Sponsors
University of Technology, Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Aged greater than or equal to 18 years old; 2) Diagnosed with Type 2 Diabetes in the preceding 12 months, and not on diabetic medication or insulin treatment; 3) Serum 25OHD is between 28 nmol/l and 85 nmol/l and not on vitamin D supplements or any relevant medications; 4) Do not have thyroid diseases, liver impairment, renal failure, cancer, osteoporosis, dementia, mental diseases or taking relevant medications; 5) Not pregnant or breastfeeding women.
Exclusion criteria
1) Unable to give written informed consent or follow the instructions in current trial; 2) are already on vitamin D supplementation or relevant diabetes control medications; 3) have liver impairment, renal failure (eGFR <50 ml/min), cancer, osteoporosis, dementia, mental disease, and thyroid diseases including hyperparathyroidism, hypercalcaemia, or taking any relevant medications; 4) are < 18 years old or are pregnant or breastfeeding women. 5) are vegen and can not ingest any animal product.
Outcome results
None listed