Health Condition 1: E063- Autoimmune thyroiditis Health Condition 2: E063- Autoimmune thyroiditis Health Condition 3: null- Subclinical Cases of Hashimotos Autoimmune Thyroiditis
Conditions
Interventions
Intervention1: Vitamin D: 60000 Units 25 Hydroxy-cholecalciferol: once weekly for 8 weeks orally, followed by once a month for 16 weeks orally.
Control Intervention1: PLACEBO: once weekly for 8 weeks
Sponsors
Institute of Postgraduate Medical Education and Research and SSKM Hospital
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Criteria based on thyroid function 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 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
| Measure | Time frame |
|---|---|
| Criteria of sonographic response is arbitrarily defined as reduction in gland size by 25 percent from baseline OR Any change in echogenicity of the whole gland or reduction in number or size of nodules by 25 percent from baseline Criteria based on anthropometric variables Responders will be arbitrarily defined as 25 percent or greater reduction in BMI in kg per square metres from baselineTimepoint: 1year | — |
Countries
India
Contacts
Public ContactDebarati Bhar
Institute of Postgraduate Medical Education and Research and SSKM Hospital
Outcome results
None listed