Determination of Effective Vitamin D Replacement and Monitoring Strategies in Vitamin D Deficiency State

NCT01430793 | Completed

• 1 other identifier: SM100404
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in vitamin D levels with specified dose and route of administration, at define intervals

  02, 04, 06 and12 months

Secondary Outcomes (1)

• Differences in the random urinary calcium to creatinine ratio in the untreated and treated state and its correlation with vitamin D levels

  00, 02, 04, 06 and 12 months

Study Arms (4)

Vitamin D 600,000 IM

ACTIVE COMPARATOR

Vitamin D3 600,000 units will be given by intramuscular injection

Drug: Vitamin D3 600,000 units IM

Vitamin D 600,000 orally

ACTIVE COMPARATOR

Vitamin D3 600,000 units will be given orally

Drug: Vitamin D3 600,000 Orally

Vitamin D 200,000 IM

ACTIVE COMPARATOR

Vitamin D3 600,000 units will be given by intramuscular injection

Drug: Vitamin D3 200,000 units IM

Vitamin D 200,000 orally

ACTIVE COMPARATOR

Vitamin D 200,000 units will be given orally

Drug: Vitamin D3 200,000 Orally

Interventions

Vitamin D3 600,000 units IM DRUG

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

Also known as: Cholecalciferol

Vitamin D 600,000 IM

Vitamin D3 600,000 Orally DRUG

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

Also known as: Cholecalciferol

Vitamin D 600,000 orally

Vitamin D3 200,000 units IM DRUG

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

Also known as: Cholecalciferol

Vitamin D 200,000 IM

Vitamin D3 200,000 Orally DRUG

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

Also known as: Cholecalciferol

Vitamin D 200,000 orally

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with Vitamin D level less than 20 ng/dl

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

• Masood MQ, Khan A, Awan S, Dar F, Naz S, Naureen G, Saghir S, Jabbar A. COMPARISON OF VITAMIN D REPLACEMENT STRATEGIES WITH HIGH-DOSE INTRAMUSCULAR OR ORAL CHOLECALCIFEROL: A PROSPECTIVE INTERVENTION STUDY. Endocr Pract. 2015 Oct;21(10):1125-33. doi: 10.4158/EP15680.OR. Epub 2015 Jul 7.

  PMID: 26151421 DERIVED

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

• Muhammad Q Masood, MBBS; FACP

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Abdul Jabbar, MBBS; FRCP

  Aga Khan University

  STUDY CHAIR

• Aysha Habib, MBBS; FCPS

  Aga Khan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 8, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

PA (1)