UMIN-CTR Clinical Trial

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
Email	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
Email	ashfaq.nutrition@gmail.com

Sponsor
Institute	AUP
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056452