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Comparison of Daily Versus Weekly Levothyroxine in Hypothyroidism patients

A Randomized Control Trial of Efficacy and Safety of Daily Versus Weekly Levothyroxine T4 in Hypothyroidism - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065960
Enrollment
56
Registered
2024-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: E039- Hypothyroidism, unspecified

Interventions

Intervention1: Levothyroxine: Levothyroxine will be given once weekly for 12 weeks Control Intervention1: Levothyroxine: Levothyroxine will be given once daily for 12 weeks.

Sponsors

All India Institute of Medical Sciences Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Known case of Primary Hypothyroidism 2.Patients willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1.Pregnancy and lactating women 2.Patients requiring Levothyroxine dose more than 150 mcg or less than 25 mcg 3.Critical care illness requiring hospitalization in ICU 4.Known cases of pituitary disorders 5.Women currently on Oral Contraceptives Pills or planning to take OCPs 6.Chronic Kidney disease patients with serum creatinine more than 1.8 7.Known cases of nephrotic syndrome 8.All patients diagnosed with Rheumatoid Arthritis 9.Patients with TSH more than 20 milli international unit per liter

Design outcomes

Primary

MeasureTime frame
1. To compare the change in thyroid hormone (T3, T4, TSH) levels between two groupsTimepoint: Baseline and 12 weeks

Secondary

MeasureTime frame
To compare the adverse events between two treatment groupsTimepoint: Baseline and 12 weeks;To compare the laboratory parameters namely LDL, hsCRP, CBC, Urinary protein and NT-pro BNP in two study groups.Timepoint: Baseline and 12 weeks;To compare the mean change in Quality-of-Life scores (SF-36 scaling tool) from baseline to 12 weeks.Timepoint: Baseline and 12 weeks

Countries

India

Contacts

Public ContactDr Sanchi Sukhija

Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur

sanchisukh7@gmail.com9552257731

Outcome results

None listed

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