Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001548325
Ethics application status
Approved
Date submitted
29/02/2016
Date registered
10/11/2017
Date last updated
10/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of almond supplementation on pregnancy-induced hypertension and dyslipidemia
Scientific title
Effectiveness of almonds in pregnancy-induced hypertension and dyslipidemia
Secondary ID [1] 288643 0
Nil
Universal Trial Number (UTN)
U1111-1180-1531
Trial acronym
APHD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy-induced hypertension 297822 0
Dyslipidemia during pregnancy 305058 0
Condition category
Condition code
Cardiovascular 297996 297996 0 0
Hypertension
Diet and Nutrition 304378 304378 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 304379 304379 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary intervention: whole raw almond

Dose: 10 almonds/day
Duration: 12 weeks
Mode: Eaten before breakfast

Adherance monitored through food diaries and regular phone calls (1-2 times per week)
Intervention code [1] 294059 0
Lifestyle
Comparator / control treatment
No Intervention
Control group
Active

Outcomes
Primary outcome [1] 297514 0
Resting blood pressure measured in the supine position using an automatic sphygmomanometer
Timepoint [1] 297514 0
four weeks post-randomization
Secondary outcome [1] 321277 0
Dyslipidemia, as indicated by serum lipid profile
Timepoint [1] 321277 0
eight weeks post randomization

Eligibility
Key inclusion criteria
Pregnancy-induced hypertension and/or dyslipidemia
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
any serious comorbidities

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/01/2016
Date of last participant enrolment
Anticipated
Actual
15/06/2016
Date of last data collection
Anticipated
Actual
28/09/2016
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 7629 0
Pakistan
State/province [1] 7629 0
Sindh

Funding & Sponsors
Funding source category [1] 293003 0
Government body
Name [1] 293003 0
Higher Education Commission
Country [1] 293003 0
Pakistan
Primary sponsor type
Individual
Name
Anwar-ul-Hassan Gilani
Address
Biological and Biomedical Sciences
Aga Khan University
Stadium Road, Karachi, 74800 Pakistan
Country
Pakistan
Secondary sponsor category [1] 291780 0
None
Name [1] 291780 0
Address [1] 291780 0
Country [1] 291780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294511 0
Ethics Review Committee
Ethics committee address [1] 294511 0
ERC, Aga Khan University, Stadium Road, Karachi 74800, Pakistan
Ethics committee country [1] 294511 0
Pakistan
Date submitted for ethics approval [1] 294511 0
02/02/2015
Approval date [1] 294511 0
07/09/2015
Ethics approval number [1] 294511 0
3542-BBS-ERC-15

Summary
Brief summary
Pregnancy-associated hypertension and dyslipidemia are among the major causes of maternal deaths. There are myriad of safety concerns with the use of drugs in pregnancy. Several clinical trials have indicated the beneficial effects of almond on the cardiovascular system including our recent clinical trials showing HDL increasing potential of almonds. While exploring the underlying mechanism we found amelioration of vascular dysfunction by almonds, indicating therapeutic potential in hypertension. Keeping in view the lack of almond-intervention trials on hypertensive patients we aim to conduct a randomized controlled clinical study on hypertensive and dyslipidemic pregnant women visiting the consultant clinics at the Aga Khan Maternity Hospital, Karimabad, Karachi. The objective is to access the effectiveness of almonds in pregnancy-associated hypertension and/or dyslipidemia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63970 0
Prof Anwar-ul-Hassan Gilani
Address 63970 0
Department of Biological and Biomedical Sciences
Aga Khan University
Stadium Road, Karachi 74800
Country 63970 0
Pakistan
Phone 63970 0
+92 21 3486 4571
Fax 63970 0
Email 63970 0
[email protected]
Contact person for public queries
Name 63971 0
Dr Humaira Jamshed
Address 63971 0
Department of Biological and Biomedical Sciences
Aga Khan University
Stadium Road, Karachi 74800
Country 63971 0
Pakistan
Phone 63971 0
+92 21 34864493
Fax 63971 0
Email 63971 0
[email protected]
Contact person for scientific queries
Name 63972 0
Dr Humaira Jamshed
Address 63972 0
Department of Biological and Biomedical Sciences
Aga Khan University
Stadium Road, Karachi 74800
Country 63972 0
Pakistan
Phone 63972 0
+ 92 21 34864493
Fax 63972 0
Email 63972 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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