Ginger (Zingiber officinale) and turmeric supplementation effects on quality of life, bone mass densitometry (BMD), body composition and osteoporosis related biomarkers and micro-RNAs in women with postmenoposal osteoporosis
Determination of Ginger and turmeric supplementation effects on quality of life, body composition and osteoporosis related bio-markers and micro-RNAs in women with postmenopausal osteoporosis
Design
This study is a randomized, triple-blind Phase 1 clinical trial in 100 women with postmenopausal osteoporosis. Participants will randomly be assigned into four groups to take ginger, curcumin, ginger and curcumin and placebo.
Settings and conduct
The target population are all women with postmenopausal osteoporosis referred to the specialized clinics of Tabriz University of Medical Sciences. Sampling will be done by convenience non randomized method. To conceal the allocation, the same envelope will be used in the opaque package to be numbered sequentially.
Participants/Inclusion and exclusion criteria
Inclusion criteria include natural menopause; age 45 and above; low bone density (Score T minus 2.5 and lower) and no history of fracture. Exclusion criteria include the use of birth control pills or steroids during the study; renal failure; metastatic bone disease; taking medications that affect bone metabolism other than taking calcium-D supplements and alendronate that are given to all subjects with the same dose
Intervention groups
Participants will be randomly divided into four groups to receive 1) Ginger supplement 2) Turmeric supplement 3) Ginger-Turmeric supplement and 4) Placebo. In group 1, one capsule of 1000 mg of ginger and two placebo of turmeric, in group 2, two capsules of 500 mg of turmeric and one placebo of ginger, in group 3, three capsules (two turmeric capsules and one ginger capsule), and Group 4 will receive three capsules of placebo.
Main outcome variables
Quality of life; body composition; osteocalcin; procollagen type 1 amiNo-terminal propeptide; carboxy-Terminal cross-linked telopeptides of type 1 collagen; miR422a; miR-133a; miR-21 and miR-503
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161022030424N3
Registration date:2018-04-29, 1397/02/09
Registration timing:registered_while_recruiting
Last update:2018-04-29, 1397/02/09
Update count:2
Registration date
2018-04-29, 1397/02/09
Registrant information
Name
Neda Dolatkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
dolatkhahn@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ginger (Zingiber officinale) and turmeric supplementation effects on quality of life, bone mass densitometry (BMD), body composition and osteoporosis related biomarkers and micro-RNAs in women with postmenoposal osteoporosis
Public title
Ginger (Zingiber officinale) and turmeric supplementation effects in osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Natural menopause
Age 45 and above
Menstrual cessation for 12 consecutive months
low bone density (Score T minus 2.5 and lower)
No history of fracture
Exclusion criteria:
Use Contraceptive Pills or Corticostroids During Study
Kidney disease or failure
Metastatic bone disease
Taking medications that affect bone metabolism other than taking calcium-D supplements or Alendronate that are given to all subjects with the same dose.
Malignancy
Age
From 45 years old
Gender
Female
Phase
0
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation of study participants to study groups, computer software RAS (Random Allocation Software) will be used through 4 and 8 glass block and allocation ratio of 1: 1.
Blinding (investigator's opinion)
Triple blinded
Blinding description
For concealment of the allocation, the same envelopes will be used in the opaque package to be numbered sequentially. Therefore, no participant, researcher, and statistical analyst will be aware of the type of intervention received. Envelopes will be numbered from 1 to 100. The first envelope will be given to the first person who will be included in the study and will continue to complete the sampling.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research, Tabriz University of Medical Sciences, Golgasht Str.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
IR.TBZMED.REC.1396.720
Health conditions studied
1
Description of health condition studied
Postmenopausal osteoporosis
ICD-10 code
M81.0
ICD-10 code description
Postmenopausal osteoporosis
Primary outcomes
1
Description
Quality of life
Timepoint
Evaluating the quality of life at the beginning of the study (before the intervention) and 6 months after the intervention began
Method of measurement
The Menopause Specific Quality of Life Questionnaire
2
Description
Body composition
Timepoint
Evaluating the Body composition at the beginning of the study (before the intervention) and 6 months after the intervention began
Method of measurement
Body composition analyzer
3
Description
Osteocalcin
Timepoint
Measuring serum osteocalcin at the beginning of the study (before the intervention) and 6 months after the intervention began
Method of measurement
Biochemical assay
4
Description
Procollagen type 1 amiNo-terminal Propeptide
Timepoint
Measuring serum Procollagen type 1 amiNo-terminal Propeptide at the beginning of the study (before the intervention) and 6 months after the intervention began
Method of measurement
Biochemical assay
5
Description
Caboxy-Terminal cross-linked telopeptides of type 1 collagen
Timepoint
Measuring serum Caboxy-Terminal cross-linked telopeptides of type 1 collagen at the beginning of the study (before the intervention) and 6 months after the intervention began
Method of measurement
Biochemical assay
6
Description
miR-422a (micro-RNA)
Timepoint
Measuring serum miR-422a (micro-RNA) at the beginning of the study (before the intervention) and 6 months after the intervention began
Method of measurement
Biochemical assay
7
Description
miR-133a (micro-RNA)
Timepoint
Measuring serum miR-133a (micro-RNA) at the beginning of the study (before the intervention) and 6 months after the intervention began
Method of measurement
Biochemical assay
8
Description
miR-21 (micro-RNA)
Timepoint
Measuring serum miR-21 (micro-RNA) at the beginning of the study (before the intervention) and 6 months after the intervention began
Method of measurement
Biochemical assay
9
Description
MiR-503 (micro-RNA)
Timepoint
Measuring serum MiR-503 (micro-RNA) at the beginning of the study (before the intervention) and 6 months after the intervention began
Method of measurement
Biochemical assay
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vomigone tablets manufactured by Dinah's pharmaceutical company containing 470 ± 30 mg of standarized rhizome powdered of ginger (Zingiber officinale) twice-daily with a meal in addition Curcuma placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the curcuma tablet and are free of powdered and turmeric extract twice-daily with a meal for 4 months
Category
Treatment - Other
2
Description
Intervention group: Curcuma tablets manufactured by Dinah's pharmaceutical company containing 450 mg of turmeric rhizome and 50 mg of turmeric extract twice-daily with a meal for 4 months in addition Vomigone placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the Vomigone tablet and are free of powdered ginger twice-daily with a meal for 4 months
Category
Treatment - Other
3
Description
Intervention group: Vomigone tablets manufactured by Dinah's pharmaceutical company containing 470 ± 30 mg of standarized rhizome powdered of ginger (Zingiber officinale) twice-daily with a meal in addition Curcuma tablets manufactured by Dinah's pharmaceutical company containing 450 mg of turmeric rhizome and 50 mg of turmeric extract twice-daily with a meal for 4 months
Category
Treatment - Other
4
Description
Control group: Vomigone placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the Vomigone tablet and are free of powdered ginger twice-daily with a meal in addition Curcuma placebo tablets manufactured by Dinah's pharmaceutical company, which are in shape, size, taste, smell and other appearance characteristics, are quite similar to the curcuma tablet and are free of powdered and turmeric extract twice-daily with a meal for 4 months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Neda Dolatkhah
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Street address
Physical Medicine and Rehabilitation Research Center, Emam Reza Hospital, Golghasht, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available