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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05430932
Other study ID # MKSU50-5-24
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date December 1, 2020

Study information

Verified date August 2022
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity is likely to be the disease of the 21th century. The growth of obesity is worldwide, a pandemic, and has increased globally in the last 30 years. Developed countries were more affected, but developing countries have increasingly contributed to this epidemic as they continue to modernize. The national and global burden of obesity, with its public health and financial implications, is projected to increase markedly in the next two decades. the study aimed to assess the effect of Vit D supplementation on preventing altered levels of calcium, Vit D, and parathormone after laparoscopic sleeve gastrectomy.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Adult - male or female - from 18 to 60 ages - BMI: 40 kg/m2 or > 35 kg/m2 - comorbidities e.g., hypertension and DM - conservative management for obesity failed in at least 2 years Exclusion Criteria: - BMI > 60 - history of bariatric surgery - symptomatic reflux oesophagitis - stomach cancer - active peptic ulcer disease - alcohol or drug abuse - major psychological disturbance - major eating troubles - risky anesthesia - risky surgery.

Study Design


Intervention

Procedure:
Laparoscopic sleeve gastrectomy
Laparoscopic resection of a part of the stomach to enable the patient to lose weight.

Locations

Country Name City State
Egypt Kafrelsheikh University Kafr Ash Shaykh Kafr Al Sheikh

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vitamin D level assessment Assessment of the vitamin D level after sleeve gastrectomy. 1 year
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