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Effect of vitamin D supplements on cardiometabolic risk and quality of life in premenopausal women: a randomized control trial

Effect of vitamin D supplements on cardiometabolic risk and quality of life in premenopausal women: a randomized control trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000452897
Enrollment
320
Registered
2012-04-23
Start date
2012-08-27
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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)

Sponsors

University of Malaya
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
35 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Premenopause women age 35 to 50 years old with vitamin D deficiency

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 23, 2026