NCT05430932

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

June 18, 2022

Last Update Submit

August 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vitamin D level assessment

    Assessment of the vitamin D level after sleeve gastrectomy.

    1 year

Study Arms (1)

Laparoscopic sleeve gastrectomy

EXPERIMENTAL

After sleeve gastrectomy, assessment of vitamin D, calcium and parathormone levels is performed.

Procedure: Laparoscopic sleeve gastrectomy

Interventions

Laparoscopic resection of a part of the stomach to enable the patient to lose weight.

Laparoscopic sleeve gastrectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

MeSH Terms

Conditions

Obesity, MorbidVitamin D Deficiency

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutrition

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, assistant lecturer of General Surgery

Study Record Dates

First Submitted

June 18, 2022

First Posted

June 24, 2022

Study Start

October 1, 2018

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations