Usefulness of Vitamin D Supplements and its Receptor Genetic variations in sugar patients with Infection of Foot from Southern part of India

Not yet recruiting

Conditions: healthy participants without a previous history of diabetes
Type 1 diabetes mellitus with other specified complications, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,

Registration Number: CTRI/2019/09/021029

Lead Sponsor: Manipal Center for Infectious Diseases

Brief Summary: A prospective cohort study will be conducted to investigate the role of vitamin D in patients with diabetic foot infection (DFI) among South-Indian population. To study the association between vitamin D status and development of foot infection in DFU patients, 80 patients with diabetic foot ulcers (DFU) will be followed up for 4 months to observe the outcome. And to determine the effect of Vitamin D supplementation in clinical and biochemical outcomes; and Quality of life (QoL) among DFI patients, 196 DFI patients will be followed for 4 months. They will be categorized into reference group (RG) and study group (SG). RG patients will not be on vitamin D supplements and SG patients will receive vitamin D supplements. A cross-sectional study will be conducted among 50 subjects each from 4 groups [DFI, DFU (without infection), diabetes patients (without ulcer) and healthy controls] to elucidate VDR gene polymorphisms. The four VDR SNPs: BsmI (SNP ID: rs1544410), ApaI (SNP ID: rs7975232), TaqI (SNP ID: rs731236) and FokI (SNP ID: rs2228570) will be genotyped using TaqMan SNP genotyping assay by a real-time polymerase chain reaction (PCR).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 476

Inclusion Criteria

1.Both genders 2.Age 18 years or older 3.Patients with type 1 or 2 DM 4.Newly diagnosed foot ulcers 5.IDSA: uninfected.
(For DFU patients) 6.IDSA: mild/moderate (For DFI patients) 7.Volunteers without a previous history of DM who has come for regular health check-up or blood donation (healthy controls) 8.Participants willing to give the informed consent form and participate in the study.

Exclusion Criteria

1.Individuals with hepatic disease, renal disease, or other comorbidities that can alter vitamin D levels 2.Diagnosis of lower limb critical ischemia by Doppler ultrasound and ankle/arm index less than 0.5 3.Patients with lower limb ulcers with distal necrosis 4.Patients having clinical evidence of vascular insufï¬ciency 5.Patients currently on steroid (use in the past 30 days) cytotoxic drugs, immunosuppressants, Calcium supplements, multivitamins, and drugs that could alter vitamin D status 6.Pregnant or breastfeeding women.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life (HRQoL)	4 months
Clinical Wound Healing	4 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	4 months

Trial Locations

Locations (1): Kasturba hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba hospital
🇮🇳Udupi, KARNATAKA, India
Shilia Jacob Kurian
Principal investigator
09886078058
shilia.kurian@learner.manipal.edu