Thyroid Hormone Dose Adjustment in Pregnancy

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00230802
• Collaborator: Harvard Medical School (HMS and HSDM) (Other)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy; Hypothyroidism	Drug: Anticipatory dose increase of levothyroxine; Drug: levothyroxine; Drug: levothyroxine	N/A

Detailed Description

Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 tablet increase Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)	Drug: Anticipatory dose increase of levothyroxine; as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.; Other Names: Levoxyl, Synthroid, Unithroid ; Drug: levothyroxine; patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week; Other Names: levoxyl, synthroid unithroid
Active Comparator: 3 tablet increase Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).	Drug: Anticipatory dose increase of levothyroxine; as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.; Other Names: Levoxyl, Synthroid, Unithroid ; Drug: levothyroxine; patients will increase levothyroxine by 3 extra tablets of their current dose per week.; Other Names: Levoxyl, Synthroid, Unithroid

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation [9 months]

   The proportion of patients in each treatment arm euthyroid through gestation

Secondary Outcome Measures

1. the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State [9 months]

2. Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy

• less than 8 weeks pregnant

Exclusion Criteria:

• cardiac disease, renal failure

• not euthyroid biochemically within 6 months pre-pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• Harvard Medical School (HMS and HSDM)

Investigators

• Principal Investigator: Erik Alexander, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erik K. Alexander, Associate Professor of Medicine, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT00230802
• Other Study ID Numbers: DK44128 (completed)
• First Posted: Oct 3, 2005
• Last Update Posted: Dec 23, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Erik K. Alexander, Associate Professor of Medicine, Brigham and Women's Hospital: pregnancy; hypothyroidism; levothyroxine
• Additional relevant MeSH terms: Hypothyroidism

Study Results

Participant Flow

Arm/Group Title	2 Tablet Increase	3 Tablet Increase
Arm/Group Description	Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)	Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
Period Title: Overall Study
STARTED	25	23
COMPLETED	25	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	2 Tablet Increase	3 Tablet Increase	Total
Arm/Group Description	Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)	Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).	Total of all reporting groups
Overall Participants	25	23	48
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	23 100%	48 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29 (3)	28 (5)	29 (5)
Gender (Count of Participants)
Female	25 100%	23 100%	48 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	23 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation
Description	The proportion of patients in each treatment arm euthyroid through gestation
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

proportion of patients in each treatment arm euthyroid through gestation

Arm/Group Title	2 Tablet Increase	3 Tablet Increase
Arm/Group Description	Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)	Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
Measure Participants	25	23
Number [participants]	24 96%	21 91.3%

2. Secondary Outcome

Title	the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2 Tablet Increase	3 Tablet Increase
Arm/Group Description	Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase) Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts. levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week	Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%). Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts. levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week.
Measure Participants	25	23
Number [participants]	10 40%	16 69.6%

3. Secondary Outcome

Title	Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2 Tablet Increase	3 Tablet Increase
Arm/Group Description	Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase) Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts. levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week	Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%). Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts. levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week.
Measure Participants	25	23
Number [participants]	25 100%	23 100%

Adverse Events

Arm/Group Title	2 Tablet Increase		3 Tablet Increase
Arm/Group Description	Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)		Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
All Cause Mortality
	2 Tablet Increase		3 Tablet Increase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	2 Tablet Increase		3 Tablet Increase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	2 Tablet Increase		3 Tablet Increase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.