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

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

Interventions

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

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

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

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

Sponsors & Collaborators

• Aga Khan University

  lead OTHER

Principal Investigators

• Muhammad Q Masood, MBBS; FACP · Aga Khan University

• Abdul Jabbar, MBBS; FRCP · Aga Khan University

• Aysha Habib, MBBS; FCPS · Aga Khan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2013-03-31

Completion

2013-03-31

Countries

• Pakistan

Study Locations