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Evaluation of impact of vitamin-D on circulating thyroid autoantibodies in autoimmune primary hypothyroidism

Impact of vitamin-D supplementation on thyroid autoimmunity in patients with autoimmune primary hypothyroidism (Hashimotos thyroiditis): A randomized controlled trial - VDAT Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005713
Enrollment
200
Registered
2015-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Newly diagnosed patients with primary hypothyroidism within the past three months of presentation to Endocrine Clinic of the Hospital

Interventions

Intervention1: Group A Treatment Group: Patients receiving vitaminâ??D supplementation cholecalciferol 60000 U (D-Rise sachets USV Mumbai India) once weekly for 8 weeks and thereafter once monthly fo

Sponsors

Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive patients diagnosed with primary hypothyroidism for the first time attending the endocrine clinic or in the last 3 months before presentation to the clinic who may or may not have been initiated on levothyroxine with initial TSH at diagnosis greater than 20 mU per liter

Exclusion criteria

Exclusion criteria: Patients with associated severe co-morbid states like chronic kidney disease, liver disease, cardiac disease, malignancy, epilepsy, tuberculosis, immunodeficiency, on chronic medication, which can interfere with thyroid hormone or vitamin-D metabolism, and pregnant ladies will be excluded. Patients who received vitamin-D and calcium supplementation in the last 6 months will also be excluded.

Design outcomes

Primary

MeasureTime frame
Normalization of TSH and reduction in anti thyroid peroxidase antibody titersTimepoint: Every 3 Months for Period of 3 Years

Secondary

MeasureTime frame
NILTimepoint: Not Applicable

Countries

India

Contacts

Public ContactSandeep Chaudhary

Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

deepdutta2000@yahoo.com9911544096

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 13, 2026