Determination of Effective Vitamin D Replacement and Monitoring Strategies in Vitamin D Deficiency State (EVIREST-D)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Muhammad Qamar Masood, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01430793
First received: September 6, 2011
Last updated: April 7, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: November 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430793

Locations
Pakistan
Aga Khan University Hospital
Karachi, Sind, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
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: April 7, 2014
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 April 15, 2014