Trial Outcomes & Findings for Diet and Hereditary Haemorrhagic Telangiectasia (NCT NCT01692015)

Results Overview

Dietary food item iron content assessed by the European Prospective Investigation into Cancer and Nutrition (EPIC) food frequency questionnaire. This method has been validated against the gold standard for dietary assessment, a 7-day weighed food diary. Questions are asked about consumption of 130 major food items over the previous year, requiring participants to indicate the frequency of consumption, and to provide details about the methods of cooking, type of produce, and use of dietary supplements. The EPIC FFQ has been widely validated in a number of studies and is deemed an adequate assessment tool to assess dietary intake.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

1 year

Results posted on

2024-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Hereditary Hemorrhagic Telangiectasia (HHT) Patients with hereditary hemorrhagic telangiectasia (HHT)
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hereditary Hemorrhagic Telangiectasia (HHT) n=50 Participants Patients with hereditary hemorrhagic telangiectasia (HHT)
Age, Continuous	55 years n=50 Participants
Sex: Female, Male Female	22 Participants n=50 Participants
Sex: Female, Male Male	28 Participants n=50 Participants
Region of Enrollment United Kingdom	50 participants n=50 Participants

PRIMARY outcome

Timeframe: 1 year

Dietary food item iron content assessed by the European Prospective Investigation into Cancer and Nutrition (EPIC) food frequency questionnaire. This method has been validated against the gold standard for dietary assessment, a 7-day weighed food diary. Questions are asked about consumption of 130 major food items over the previous year, requiring participants to indicate the frequency of consumption, and to provide details about the methods of cooking, type of produce, and use of dietary supplements. The EPIC FFQ has been widely validated in a number of studies and is deemed an adequate assessment tool to assess dietary intake.

Outcome measures

Outcome measures
Measure	Hereditary Hemorrhagic Telangiectasia (HHT) n=50 Participants Patients with hereditary hemorrhagic telangiectasia (HHT)
Number of Participants That Achieving Personal Recommended Intake of Iron	43 Participants

PRIMARY outcome

Timeframe: 3 months

Nosebleeds were quantified using the validated Epistaxis Severity Score (ESS). The six questions provide an objective measure of nosebleeds: three relate to different characteristics of typical nosebleeds within the previous three months (frequency, duration and intensity (gushing/pouring or not)), three to medical attention, anemia and transfusion requirements. The final ESS score ranges from 0-10, where a higher score equates to greater blood losses.

Outcome measures

Outcome measures
Measure	Hereditary Hemorrhagic Telangiectasia (HHT) n=50 Participants Patients with hereditary hemorrhagic telangiectasia (HHT)
Nosebleed Severity	4.4 units Interval 0.0 to 9.1

PRIMARY outcome

Timeframe: 1 year

The hemorrhage-adjusted iron requirement (HAIR) was calculated as the sum of the normal recommended dietary iron intake, and requirements to compensate for non-menstrual blood losses.

Outcome measures

Outcome measures
Measure	Hereditary Hemorrhagic Telangiectasia (HHT) n=50 Participants Patients with hereditary hemorrhagic telangiectasia (HHT)
Number of Participants That Achieving the Hemorrhage Adjusted Iron Requirement (HAIR)	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: 25 participants were filled up the 7-day weighed food diary

Chocolate can precipitate nosebleeds Food items intake assessed by 7-day weighed food diary

Outcome measures

Outcome measures
Measure	Hereditary Hemorrhagic Telangiectasia (HHT) n=25 Participants Patients with hereditary hemorrhagic telangiectasia (HHT)
Number of Participants That Ingested Chocolate	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: 25 participants were filled up the 7-day weighed food diary

Bread not precipitate nosebleeds Food items intake assessed by 7-day weighed food diary

Outcome measures

Outcome measures
Measure	Hereditary Hemorrhagic Telangiectasia (HHT) n=25 Participants Patients with hereditary hemorrhagic telangiectasia (HHT)
Number of Participants That Ingested Bread	25 Participants

Adverse Events

Hereditary Hemorrhagic Telangiectasia (HHT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

professor Claire Shovlin

Imperial College London

Phone: +44 (0)20 7589 5111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place