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Completed

NCT Number: NCT00956839

Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis

The purpose of this study is to determine the efficacy of 2 different doses of intramuscular (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in the blood of patients with tropical calcific pancreatitis.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

About this study

Tropical calcific pancreatitis (TCP) is a form of chronic pancreatitis unique to developing countries. Patients with TCP often have malabsorption leading to nutritional deficiencies. We have noted that vitamin D deficiency is common in patients with TCP. The ideal regimen for supplementing vitamin D3 in chronic pancreatitis remains unclear and there are no previous studies available. High dose oral vitamin D2 has been shown to be ineffective in normalizing vitamin D levels in patients with pancreatic insufficiency due to cystic fibrosis.

Intramuscular (IM) vitamin D3 supplementation in chronic pancreatitis has certain advantages. Firstly, decreased and inconsistent absorption from the intestine is avoided. Secondly, IM vitamin D3 has a long duration of action (6-12 months). The safety of high-dose IM vitamin D3 has been proven in previous studies in healthy individuals. Finally, the injection form is considerably less expensive as compared to oral vitamin D3.

The aim of the current prospective double blind study is to compare 2 regimens of high dose IM vitamin D3 replenishment with oral vitamin D3 in standard recommended doses in normalizing serum vitamin D3 levels in patients with TCP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of tropical calcific pancreatitis established by history of abdominal pain or diabetes and evidence on ultrasound or CT scan of pancreatic ductal dilatation and intra-ductal stones

Exclusion criteria

  • History of alcohol intake or any secondary cause for chronic pancreatitis (hypercalcemia, hypertriglyceridemia, biliary tract stones)
  • History of hepatic or renal dysfunction or of current intake of drugs such as steroids, anticonvulsant drugs

Treatment and study plan

Vitamin D3 (cholecalciferol)

Drug

Arm 1 - Intramuscular vitamin D3 3,00,000 Units single dose

Arm 2 - Intramuscular vitamin D3 6,00,000 Units single dose

Arm 3 - Oral vitamin D3 500 Units/day for 6 months

Other names: IM vitamin D3 - Inj Arachitol (Solvay, India), Oral vitamin D3 - Tab Cipcal (Cipla, India)

Primary outcomes

  1. Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml

    Time frame: 6 months post intervention

    Percentage of patients in each group with serum 25 hydroxy vitamin D >30 ng/ml

Secondary outcomes

  1. Serum Total Calcium

    Time frame: 0, 1, 3, 6 months post intervention

    Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months

Sponsors and collaborators

Lead sponsor

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Other Gov

Registry information

Official study title

Double-blind Randomized Study to Determine the Efficacy of Intramuscular Vitamin D3 Supplementation in Tropical Calcific Pancreatitis

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2009
Registry last updated
Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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