UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049569 |
|---|---|
| Receipt number | R000056452 |
| Scientific Title | EFFECT OF DIET HIGH IN ENERGY, PROTEIN, IRON, ZINC AND VITAMIN A ON BODY WEIGHT AND NUTRITIONAL STATUS IN PATIENTS WITH TUBERCULOSIS |
| Date of disclosure of the study information | 2022/11/21 |
| Last modified on | 2022/11/21 09:34:33 |
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Basic information
Public title
EFFECT OF DIET HIGH IN ENERGY, PROTEIN, IRON, ZINC AND VITAMIN A ON BODY WEIGHT AND NUTRITIONAL STATUS IN PATIENTS WITH TUBERCULOSIS
Acronym
EFFECT OF DIET HIGH IN ENERGY, PROTEIN, IRON, ZINC AND VITAMIN A ON BODY WEIGHT AND NUTRITIONAL STATUS IN PATIENTS WITH TUBERCULOSIS
Scientific Title
EFFECT OF DIET HIGH IN ENERGY, PROTEIN, IRON, ZINC AND VITAMIN A ON BODY WEIGHT AND NUTRITIONAL STATUS IN PATIENTS WITH TUBERCULOSIS
Scientific Title:Acronym
EFFECT OF DIET HIGH IN ENERGY, PROTEIN, IRON, ZINC AND VITAMIN A ON BODY WEIGHT AND NUTRITIONAL STATUS IN PATIENTS WITH TUBERCULOSIS
Region
| Asia(except Japan) |
Condition
Condition
Tuberculosis infection of TB patients admitted in TB Clinics in Mardan, KPK, Pakistan
Classification by specialty
| Infectious disease | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of various nutrition formulations on weight changes in TB patients
Basic objectives2
Others
Basic objectives -Others
The primary objectives of this study is to investigate the effect of high caloric protein, iron, zinc and vitamin-A diet on the weight and nutritional status of tuberculosis patients
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
weight changes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Nutrition formulations
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
The subjects selection criterion for both nutritional and control patients were:
newly diagnosed pulmonary tuberculosis patient (diagnosed within 1-2 weeks before the commencement of the study
Key exclusion criteria
The subjects exclusions criteria were:
Other than PTB, patientwith other infection or disease (e.g. Diabetes, CVD, etc, Patients hypersensitivity to anti-tuberculosis treatment drugs
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Muhammad |
| Middle name | Ashfaq Ur |
| Last name | Rahman |
Organization
AUP
Division name
Human Nutrition and Dietetics
Zip code
25000
Address
AUP Khyber Pakhtunkhwa Province, Pakistan 25000
TEL
00923455104041
ashfaq.nutrition@gmail.com
Public contact
Name of contact person
| 1st name | Muhammad |
| Middle name | Ashfaq Ur |
| Last name | Rahman |
Organization
AUP
Division name
Human Nutrition and Dietetics
Zip code
25000
Address
AUP, Khyber Pakhtunkhwa Province, Pakistan 25000
TEL
00923455104041
Homepage URL
ashfaq.nutrition@gmail.com
Sponsor or person
Institute
AUP
Institute
Department
Personal name
Funding Source
Organization
AUP
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NEAT
Address
NEAT, Charsadda, Khyber Pakhtoonkhwa (KPK), Pakistan
Tel
00923111992285
dr.qazinoor@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
http://aup.edu.pk
Publication of results
Partially published
Result
URL related to results and publications
www,aup.edu.pk
Number of participants that the trial has enrolled
30
Results
All diets tested show significant effect on weight gain in patients with TB as compared to the control
Results date posted
| 2022 | Year | 11 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age range 40-80
All male
BMI+mostly normal
Participant flow
Not applicable
Adverse events
None reported
Outcome measures
weight
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 21 | Day |
Last modified on
| 2022 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056452
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| Registered date | File name |
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