Determination of Effective Vitamin D Replacement and Monitoring Strategies in Vitamin D Deficiency State (EVIREST-D)
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Purpose
The purpose of the study is determination of effective vitamin D replacement strategy in vitamin D deficiency states with currently available preparations in Pakistan & to determine the cost effective monitoring strategy with urinary calcium excretion serving as a surrogate marker of achievement of vitamin D sufficiency state.
The study will be conducted at the out-patient Endocrinology Clinics of the Aga Khan University Hospital, Karachi, Pakistan. All patients seen in endocrine clinics with Vitamin D level less than 20 ng and do not have any of exclusion criteria mentioned below will be eligible for recruitment in the study. The study participants will be randomly assigned into 4 groups for intervention to receive intramuscular or oral Vitamin D in 200,000 or 600,000 units as per group allocation. Each group will comprise of 25 participants.
Group 1: Vitamin D3 600,000 units IM and then every 2 monthly for 2 times if levels remain < 30 ng/ml.
Group 2: Vitamin D3 600,000 units orally and then every 2 monthly for 2 times if levels remain < 30 ng/ml.
Group 3: Vitamin D3 200,000 units IM initially and then every 2 monthly for 2 months if levels remain < 30 ng/ml.
Group 4: Vitamin D3 200,000 units orally initially and then every 2 monthly for 2 times if levels remain < 30 ng/ml.
All patients will be prescribed elemental Calcium 1 gram /day. Vitamin D levels along with the other biochemical parameter and random urine for calcium & creatinine will be checked at 00, 02, 04, 06 and 12 months.
| Condition | Intervention |
|---|---|
|
Vitamin D Deficiency |
Drug: Vitamin D3 600,000 units IM Drug: Vitamin D3 600,000 Orally Drug: Vitamin D3 200,000 units IM Drug: Vitamin D3 200,000 Orally |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vitamin D Dosing and Monitoring Study |
- Change in vitamin D levels with specified dose and route of administration, at define intervals [ Time Frame: 02, 04, 06 and12 months ] [ Designated as safety issue: No ]
- Differences in the random urinary calcium to creatinine ratio in the untreated and treated state and its correlation with vitamin D levels [ Time Frame: 00, 02, 04, 06 and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vitamin D 600,000 IM
Vitamin D3 600,000 units will be given by intramuscular injection
|
Drug: Vitamin D3 600,000 units IM
Vitamin D3 600,000 units will be given by Intramuscular injection and then will be repeated every 2 monthly for 2 times if vitamin D levels remain < 30 ng/ml
Other Name: Cholecalciferol
|
|
Active Comparator: Vitamin D 600,000 orally
Vitamin D3 600,000 units will be given orally
|
Drug: Vitamin D3 600,000 Orally
Vitamin D3 600,000 units will be given orally and then will be repeated every 2 monthly for 2 times if vitamin D levels remain < 30 ng/ml
Other Name: Cholecalciferol
|
|
Active Comparator: Vitamin D 200,000 IM
Vitamin D3 600,000 units will be given by intramuscular injection
|
Drug: Vitamin D3 200,000 units IM
Vitamin D3 200,000 units will be given by Intramuscular injection and then will be repeated every 2 monthly for 2 times if level of vitamin D remain < 30 ng/ml
Other Name: Cholecalciferol
|
|
Active Comparator: Vitamin D 200,000 orally
Vitamin D 200,000 units will be given orally
|
Drug: Vitamin D3 200,000 Orally
Vitamin D3 200,000 units will be given by orally and then will be repeated every 2 monthly for 2 times if level of vitamin D remain < 30 ng/ml
Other Name: Cholecalciferol
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients with Vitamin D level less than 20 ng/dl
Exclusion Criteria:
- Patients who have received vitamin D injection in last 03 months.
- Patients with hypercalcemia (corrected calcium > 10.6 mg/dl)
- Known Malignancy.
- Known case of CLD or serum ALT > 3 times ULN
- Patients with creatinine > 2.0 mg/dl.
Contacts and Locations| Contact: Muhammad Q Masood, MBBS; FACP | 92-3486-4366 | qamar.masood@aku.edu |
| Contact: Aysha Habib, MBBS; FCPS | 92-3486-1926 | aysha.habib@aku.edu |
| Pakistan | |
| Aga Khan University Hospital | Recruiting |
| Karachi, Sind, Pakistan, 74800 | |
| Principal Investigator: Muhammad Q Masood, MBBS; FACP | |
| Principal Investigator: | Muhammad Q Masood, MBBS; FACP | Aga Khan University |
| Study Chair: | Abdul Jabbar, MBBS; FRCP | Aga Khan University |
| Study Director: | Aysha Habib, MBBS; FCPS | Aga Khan University |
More Information
No publications provided
| Responsible Party: | Muhammad Qamar Masood, Assistant Professor, Department of Medicine, Aga Khan University |
| ClinicalTrials.gov Identifier: | NCT01430793 History of Changes |
| Other Study ID Numbers: | SM100404 |
| Study First Received: | September 6, 2011 |
| Last Updated: | May 15, 2012 |
| Health Authority: | Pakistan: Research Ethics Committee |
Additional relevant MeSH terms:
|
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Cholecalciferol Vitamin D |
Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 17, 2013