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Effect of vitamin D replacement on functions of blood vessels in patients with vitamin D deficiency after correcting thyroid hormone deficiency

Effect of vitamin D replacement on vascular functions in vitamin D deficient treated hypothyroid patients â?? a randomized double blinded placebo controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008267
Enrollment
88
Registered
2017-03-30
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- Vitamin D deficient hypothyroid patients

Interventions

Intervention1: Vitamin D: Tablet vitamin D 60,000 IU one tablet once weekly for 8 weeks in addition to standard background therapy(Tablet Levothyroxine) Control Intervention1: Placebo: Matching placeb

Sponsors

JIPMER intramural
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. Newly diagnosed hypothyroid patients with TSH >10mIU/L ii. Vitamin D deficiency

Exclusion criteria

Exclusion criteria: i.Liver dysfunction (AST,ALT > 2 times the upper limit of normal) ii.Renal dysfunction (GFR iii.Patient with concurrent illnesses like Diabetes mellitus, Hypertension, CAD (Coronary Artery Disease), CVA(cerebrovascular accidents), PVD (Peripheral Vascular Disease), CKD (Chronic Kidney Disease), renal calculi, thyroid and other malignancy, those on concurrent treatment for tuberculosis, bariatric surgery procedure or malabsorption disorders and any clinical indication for vitamin D treatment. iv.Pregnant women or lactating mothers. v.Patients who had participated in other trials in the past three months. vi.Smokers vii.Alcoholics viii.Patients taking medication like glucocorticoids, anti-retroviral agents, orlistat

Design outcomes

Primary

MeasureTime frame
Carotid femoral pulse wave velocityTimepoint: Baseline, before starting vitamin D and 8 weeks after starting vitamin D

Secondary

MeasureTime frame
hsCRP, IL-6, IL-10 and TNF-αTimepoint: Before starting vitamin D or placebo, 8 wks after starting vitamin D or placebo

Countries

India

Contacts

Public ContactDr Sadishkumar Kamalanathan

JIPMER, Puducherry

dr.ravee@gmail.com9442173134

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026