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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
Sponsor:
Collaborator:
Universiti Teknologi Mara
Information provided by (Responsible Party):
Sharifah Faradila bt Wan Muhamad Hatta, University of Malaya

Brief 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).


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D3 Phase 4

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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

Resource links provided by the National Library of Medicine


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.
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Post menopausal osteoporosis woman receiving treatment from the Osteoporosis Clinic, University of Malaya Medical Centre, Kuala Lumpur.
  2. Resident in Malaysia, of South Indian descent or Muslim Malay wearing headscarf
  3. Baseline serum 25(OH)D levels > 20 ng/ml

Exclusion Criteria:

  1. Secondary osteoporosis e.g. glucocorticoid induced osteoporosis
  2. Metabolic bone disease e.g. hypercalcaemia, primary hyperparathyroidism, hyperthyroidism, hypothyroidism, Paget's disease
  3. 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
  4. Calculated Creatinine Clearance of < 60 mls/min
  5. Liver disease and Malabsorptive Diseases e.g. celiac disease, radiation, enteritis, active inflammatory bowel disease
  6. Malignancy

Information from the National Library of Medicine

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


Contacts
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Contact: sharifah faradila wan muhamad hatta, MBBCh,MRCP 0060172397371 shfara@gmail.com
Contact: NurBazlin Musa, BBMED 0060379492622 nur_bazlin@yahoo.com

Locations
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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   
Sponsors and Collaborators
Sharifah Faradila bt Wan Muhamad Hatta
Universiti Teknologi Mara
Investigators
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Principal Investigator: Shireene Ratna Vethakkan, MBBS,MMED,MD University of Malaya Medical Centre

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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
Keywords provided by Sharifah Faradila bt Wan Muhamad Hatta, University of Malaya:
Vitamin D Deficiency
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents