Determination of Vitamin D Dose to Maintain Sufficiency Amongst Indian and Malay Women in the Tropics

NCT02389179 | Unknown Phase 4 DMC

• 1 other identifier: Vitamin D
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Vitamin D Deficiency

Keywords

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Measuring optimal Vitamin D dose required to maintain vitamin D sufficiency (Serum 25(OH)D >30ng/ml in Malay and Indian PMO women.

  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.

  6 months

Study Arms (3)

25 000 IU monthly

ACTIVE COMPARATOR

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

50 000 IU monthly

ACTIVE COMPARATOR

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

50 000 IU bi-weekly

ACTIVE COMPARATOR

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

Interventions

Vitamin D3 DRUG

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.

Also known as: Cholecalciferol

25 000 IU monthly; 50 000 IU bi-weekly; 50 000 IU monthly

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sharifah Faradila bt Wan Muhamad Hatta: lead
• Universiti Teknologi Mara: collaborator

Study Sites (1)

University of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Shireene Ratna Vethakkan, MBBS,MMED,MD

  University of Malaya Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sharifah faradila wan muhamad hatta, MBBCh,MRCP

CONTACT

0060172397371; shfara@gmail.com

NurBazlin Musa, BBMED

CONTACT

0060379492622; nur_bazlin@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 17, 2015
• Study Start: August 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

MY (1)