Determination of Vitamin D Dose to Maintain Sufficiency Amongst Indian and Malay Women in the Tropics
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ClinicalTrials.gov Identifier: NCT02389179 |
Recruitment Status : Unknown
Verified December 2015 by Sharifah Faradila bt Wan Muhamad Hatta, University of Malaya.
Recruitment status was: Recruiting
First Posted : March 17, 2015
Last Update Posted : December 16, 2015
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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).
Condition or disease | Intervention/treatment | Phase |
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Vitamin D Deficiency | Drug: Vitamin D3 | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Maintenance of Vitamin D Sufficiency With Oral Vitamin D Supplementation in Malaysian Women of Malay and Indian Ethnicity With Post Menopausal Osteoporosis |
Study Start Date : | August 2014 |
Estimated Primary Completion Date : | July 2016 |
Estimated Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 25 000 IU monthly
The dose stated above are doses of Vitamin D3/Cholecalciferol which is formulated as spray dried powder stabilized with DL-alpha tocopherol (dry vitamin D3 100 SD/S)(DSM Nutritional Products Switzerland Ltd). The spray dried powder will be diluted in 10 mls of water and ingested orally by subjects under direct supervision in a clinic setting.
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Drug: Vitamin D3
The drug/dosage of Vitamin D3 will be given monthly or bi-weekly depending on the type of arm that the subjects are randomised into under direct supervision.
Other Name: Cholecalciferol |
Active Comparator: 50 000 IU monthly
The dose stated above are doses of Vitamin D3/Cholecalciferol which is formulated as spray dried powder stabilized with DL-alpha tocopherol (dry vitamin D3 100 SD/S)(DSM Nutritional Products Switzerland Ltd).The spray dried powder will be diluted in 10 mls of water and ingested orally by subjects under direct supervision in a clinic setting.
|
Drug: Vitamin D3
The drug/dosage of Vitamin D3 will be given monthly or bi-weekly depending on the type of arm that the subjects are randomised into under direct supervision.
Other Name: Cholecalciferol |
Active Comparator: 50 000 IU bi-weekly
The dose stated above are doses of Vitamin D3/Cholecalciferol which is formulated as spray dried powder stabilized with DL-alpha tocopherol (dry vitamin D3 100 SD/S)(DSM Nutritional Products Switzerland Ltd).The spray dried powder will be diluted in 10 mls of water and ingested orally by subjects under direct supervision in a clinic setting.
|
Drug: Vitamin D3
The drug/dosage of Vitamin D3 will be given monthly or bi-weekly depending on the type of arm that the subjects are randomised into under direct supervision.
Other Name: Cholecalciferol |
- Measuring optimal Vitamin D dose required to maintain vitamin D sufficiency (Serum 25(OH)D >30ng/ml in Malay and Indian PMO women. [ Time Frame: 6 months ]This Randomised Control Trial will evaluate the appropriate dose of Vitamin D required to maintain sufficiency amongst Post Menopausal Malay and Indian descent Osteoporosis women.

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Ages Eligible for Study: | 45 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Post menopausal osteoporosis woman receiving treatment from the Osteoporosis Clinic, University of Malaya Medical Centre, Kuala Lumpur.
- Resident in Malaysia, of South Indian descent or Muslim Malay wearing headscarf
- Baseline serum 25(OH)D levels > 20 ng/ml
Exclusion Criteria:
- Secondary osteoporosis e.g. glucocorticoid induced osteoporosis
- Metabolic bone disease e.g. hypercalcaemia, primary hyperparathyroidism, hyperthyroidism, hypothyroidism, Paget's disease
- Medications that interfere with bone / vitamin D metabolism e.g. recombinant human parathyroid hormone i.e. Teriparatide, hormone replacement therapy (HRT), glucocorticoids, rifampicin and anticonvulsants
- Calculated Creatinine Clearance of < 60 mls/min
- Liver disease and Malabsorptive Diseases e.g. celiac disease, radiation, enteritis, active inflammatory bowel disease
- Malignancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389179
Contact: sharifah faradila wan muhamad hatta, MBBCh,MRCP | 0060172397371 | shfara@gmail.com | |
Contact: NurBazlin Musa, BBMED | 0060379492622 | nur_bazlin@yahoo.com |
Malaysia | |
University of Malaya Medical Centre | Recruiting |
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100 | |
Contact: sharifah faradila wan muhamad hatta, MBBCh, MRCP 0060172397371 shfara@gmail.com | |
Contact: Nurbazlin Musa, BBMED 0060379492622 nur_bazlin@gmail.com |
Principal Investigator: | Shireene Ratna Vethakkan, MBBS,MMED,MD | University of Malaya Medical Centre |
Responsible Party: | Sharifah Faradila bt Wan Muhamad Hatta, Doctor, University of Malaya |
ClinicalTrials.gov Identifier: | NCT02389179 |
Other Study ID Numbers: |
Vitamin D |
First Posted: | March 17, 2015 Key Record Dates |
Last Update Posted: | December 16, 2015 |
Last Verified: | December 2015 |
Vitamin D Deficiency |
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Cholecalciferol |
Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |