Effect of Vitamin D supplementation in improving Thyroid disease of mild variety

Phase 3

Completed

• Conditions: Health Condition 1: E063- Autoimmune thyroiditisHealth Condition 2: E063- Autoimmune thyroiditisHealth Condition 3: null- Subclinical Cases of Hashimotos Autoimmune Thyroiditis

• Registration Number: CTRI/2017/05/008596
• Lead Sponsor: Institute of Postgraduate Medical Education and Research and SSKM Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-08
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

Age more than 18 yrs

Gender both male and female

Positive anti TPO antibody more than 34 International Units per litre as per our hospital laboratory normal upper limit AND OR

Positive anti TG more than 20 International Units per litre as per our laboratory normal upper limit for anti TPO negative cases

Normal serum free T4 more than 1.9 nanogram per decilitre as per our laboratory normal upper limit

Exclusion Criteria

Diseases and drugs interfering with vitamin D metabolism like CKD Liver diseases chronic granulomatous diseases like TB sarcoidosis

Drugs including phenytoin phenobarbitone valproic acid cholestyramin rifampin orlistat corticosteroid or others

Any chronic medications that might interfere with thyroid hormone metabolism

Pregnant and lactating women

Those who received Vitamin D and calcium in the last 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Criteria based on thyroid function <br/ ><br> <br/ ><br>Responders will be arbitrarily defined as at least 25 percent or greater reduction in serum TSH levels in mili International Units per litre from baseline value in the Intervention group AND OR <br/ ><br> <br/ ><br>25 percent or greater reduction in serum anti TPO antibody titers in International Units per litre from baseline in the Intervention groupTimepoint: 1 year

Secondary Outcome Measures

Name	Time	Method
Criteria of sonographic response is arbitrarily defined as reduction in gland size by 25 percent from baseline OR <br/ ><br> <br/ ><br>Any change in echogenicity of the whole gland or reduction in number or size of nodules by 25 percent from baseline <br/ ><br> <br/ ><br>Criteria based on anthropometric variables <br/ ><br> <br/ ><br>Responders will be arbitrarily defined as 25 percent or greater reduction in BMI in kg per square metres from baselineTimepoint: 1year