Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000452897
Ethics application status
Approved
Date submitted
17/04/2012
Date registered
23/04/2012
Date last updated
24/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of vitamin D supplements on cardiometabolic risk and quality of life in premenopausal women: a randomized control trial
Scientific title
Effect of vitamin D supplements on cardiometabolic risk and quality of life in premenopausal women: a randomized control trial
Secondary ID [1] 280233 0
Nil
Universal Trial Number (UTN)
U1111-1129-5634
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 286182 0
cardiometabolic risk factors 286184 0
Condition category
Condition code
Diet and Nutrition 286376 286376 0 0
Other diet and nutrition disorders
Cardiovascular 286378 286378 0 0
Hypertension
Metabolic and Endocrine 286379 286379 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Vitamin D in powder form, 50,000 IU / dose. Given orally.
50,000 IU/ week for 8 weeks then 50,000 IU / month for 10 months. The vitamin D powder will be mixed with a cup of plain water and can be consume anytime of the day (before or after meal)
Intervention code [1] 284569 0
Prevention
Intervention code [2] 284724 0
Treatment: Other
Comparator / control treatment
Placebo: Starch in powder form. 0.5 mg/dose given orally weekly for 8 weeks and monthly for 10 months.
Control group
Placebo

Outcomes
Primary outcome [1] 286838 0
Improvement in any cardiometabolic risk factors such as hyperlipidaemia measured by fasting blood lipid profile, insulin resistance measure using HOMA-IR and high blood pressure
Timepoint [1] 286838 0
At baseline, 6 months and 12 months
Secondary outcome [1] 296794 0
Reduction in proportion of patients with metabolic syndromes. Metabolic syndrome is defined as the presence of three or more metabolic risk factors that exist in one person that is central obesity which is measured by waist circumference (men: > 40 inches; women: > 35 inches); fasting blood triglycerides > 150 mg/dL or taking medication for triglycerides, low HDL level (men: < 40 mg/dL; women: < 50 mg/dL) or taking medication for low HDL, fasting blood sugar of 100 mg/dL or higher or taking medication for high blood sugar (all measured by biochemical analysis test) and elevated blood pressure of 130/85 mmHg or more or taking medication for high BP (measured twice by a digital sphygmomanometer).
Timepoint [1] 296794 0
At baseline, 6 months and 12 months
Secondary outcome [2] 296795 0
Increment in serum 25(OH)D levels. The methods used for analysis of serum 25(OH)D measurement, will be using the radioimmunoassay analysis method (DiaSorin, Stillwater, MN).
Timepoint [2] 296795 0
At baseline, 6 months and 12 months
Secondary outcome [3] 296796 0
Improvement in health-related quality of life. SF-36v2 health survey will be used to assess participant?s health-related quality of life on regards to physical and emotional well being for people with vitamin D deficiency and to assess if any improvements of health-related quality of life after intervention.
Timepoint [3] 296796 0
At baseline and 12 months

Eligibility
Key inclusion criteria
Premenopause women age 35 to 50 years old with vitamin D deficiency
Minimum age
35 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking vitamin D supplements > 1000 IU/day, elevated serum calcium > 10.4 mg/dl, elevated serum PTH > 55 pg/ml, pregnant women, participants with granuloma-forming disorder such as tuberculosis

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment procedures are using the seal opaque envelope that will be kept by an independent third party who will match the participants with the allocation using the name list and allocation sequence list and put it in the envelope. The envelope will only be open by third party person when it is time to allocate the interventions during the labelling of prepacked bottles of active supplements and placebo. However, the label will only state the name of participants but not the contents to maintain the allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization sequence will be created using Stata 9.0 (StataCorp, College Station, TX) statistical software and will be a 1:1 allocation by an investigator with no clinical involvement in the trial
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment outside Australia
Country [1] 4226 0
Malaysia
State/province [1] 4226 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 284994 0
University
Name [1] 284994 0
University of Malaya, Malaysia
Country [1] 284994 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
University of Malaya, 50603, Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 283859 0
None
Name [1] 283859 0
Address [1] 283859 0
Country [1] 283859 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287001 0
Medical Ethics Committee University Malaya Medical Centre
Ethics committee address [1] 287001 0
University of Malaya Medical Centre,
Lembah Pantai,
59100, Kuala Lumpur
Malaysia
Ethics committee country [1] 287001 0
Malaysia
Date submitted for ethics approval [1] 287001 0
Approval date [1] 287001 0
21/03/2012
Ethics approval number [1] 287001 0
907.22

Summary
Brief summary
Recent evidence has indicates that apart of vitamin D classical role in musculoskeletal diseases, vitamin D deficiency also associated with cardiometabolic risk factors such as hypertension, diabetes mellitus and hypercholesterol. Although Malaysia is a sunshine-abundant country, recent studies have found that the prevalence of vitamin D deficiency is significantly high. However, no study done to measure its effect on cardiometabolic risk factors in Malaysia with very limited clinical trials globally to measure the relationship between vitamin D and both the cardiometabolic risk and quality of life. This is a parallel randomized placebo control trial that investigating the effect of vitamin D supplements on both the cardiometabolic risk and quality of life in urban healthy population in Kuala Lumpur, Malaysia. The objective of this study is to investigate whether vitamin D supplements can reduce the cardiometabolic risk and quality of life in urban premenopausal women with vitamin D deficiency.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33991 0
Address 33991 0
Country 33991 0
Phone 33991 0
Fax 33991 0
Email 33991 0
Contact person for public queries
Name 17238 0
Mazliza Ramly
Address 17238 0
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia
Country 17238 0
Malaysia
Phone 17238 0
+60133406326
Fax 17238 0
Email 17238 0
marzmie@yahoo.com
Contact person for scientific queries
Name 8166 0
Mazliza Ramly
Address 8166 0
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia
Country 8166 0
Malaysia
Phone 8166 0
+60133406326
Fax 8166 0
Email 8166 0
marzmie@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.