Determination of Vitamin D Dose to Maintain Sufficiency Amongst Indian and Malay Women in the Tropics
Status:
Unknown status
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
Much research on vitamin D status has focused on seasonal variations in serum 25(OH)D levels
in populations living at high altitudes and those of light-skinned Caucasian extraction, with
little work done in multi ethnic populations living closer to the equator with regards to
Vitamin d supplementation, prevalence, predictors and associations of hypovitaminosis D - the
assumption, perhaps being vitamin D deficiency is unlikely in locations of plentiful
sunshine. There is a dearth of studies on Vitamin D status in a group of subjects at
especially high risk of falls/fractures i.e. post-menopausal women with osteoporosis living
in South-East Asia. It is possible that differences in geography and ethnicity/culture
amongst women with post menopausal osteoporosis (PMO) in Malaysia may necessitate
supplemental Vitamin D doses that differ from those prescribed to North American Caucasians.
There is no unified consensus on the dose of Vitamin D supplementation. Neither is there
agreement on definitions of sufficiency with some researchers targeting levels of serum
25(OH)D of >20ng/ml and others aiming for levels above 30ng/ml. The Institute of Medicine
(IOM) 2010 guidelines, aiming for a lower serum 25(OH)D target of 20ng/ml, advocates
maintenance doses of 600 IU/day in Postmenopausal women aged 51-70 and 800 IU/day for those
aged >70 years. On contrary, the Endocrine Society 2011 guidelines state that maintenance
doses up to 1500-2000 IU/day may be required to attain a higher optimal target of >30ng/ml.
On addition, the 2014 National Osteoporosis Foundation Guidelines recommended that the
Vitamin D level should be brought up to approximately 30ng/ml, and to maintain at this level
taking into account those with limited sun exposure, obese and dark skin individuals, the
daily requirement ranges from 800-2000 IU/day.
The investigators therefore designed a prospective randomized controlled trial comparing
efficacy and safety of a low (900 IU/day) and high (1800IU/day and 3300IU/day) maintenance
dose of Cholecalciferol (Vitamin D3) amongst community dwelling Indian and Malay with PMO
living in Kuala Lumpur, Malaysia.
Hypothesis of the study is despite abundant exposure to sunlight, which is the main Vitamin D
supplier, those who dress conservatively and individuals with darker skin may require a
higher dose of Vitamin D to maintain sufficiency (>30ng/ml).
Phase:
Phase 4
Details
Lead Sponsor:
Sharifah Faradila bt Wan Muhamad Hatta
Collaborator:
Universiti Teknologi Mara
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins