Protocol summary
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Study aim
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To determine and comparison of the effect of Curcumin, Nigella Sativa, Curcumin and Nigella Sativa on cellular-molecular and clinical outcomes in postmenopausal women with primary osteoporosis.
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Design
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In this triple-blind randomized, controlled trial with four parallel arms, 120 postmenopausal women with primary osteoporosis will be randomly assigned into four groups using block randomization with block sizes of 4 and 8, and the ratio of 1: 1: 1: 1, receiving 1) Nigella Sativa, 2) Curcumin nano-missile, 3) Nigella Sativa and Curcumin nano-missile, or 4) both placebo, and will receive the intervention for 6 months.
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Settings and conduct
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Eligible women will be selected using the information available in Tabriz's health centers, after necessary assessments and receiving written informed consent and will be randomized into one of the four groups, receiving the treatments for six months. Participants, investigators, and statistical analyst will be blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Postmenopausal women aged 50 to 65; Low bone density (T-score <-2.5) in lumbar spine or hip (total and femoral neck)
Exclusion criteria: T-score≤-4 in the lumbar spine, T-score≤-3.5 in the hip and femoral neck; taking drugs affecting bone metabolism; systemic diseases and hormonal disorders; coagulation disorders; gastrointestinal ulcers; gallstone
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Intervention groups
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Receiving the following daily treatments:
group 1: one 1000 mg Nigella Sativa oil capsule and one Curcumin placebo;
group 2: one 80 mg Curcumin-nanomicelle capsule and one Nigella Sativa placebo
group 3: one Curcumin and one Nigella Sativa capsule; and
group 4: placebo of both drugs.
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Main outcome variables
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Bone mineral density, serum levels of bone turnover markers (Osteocalcin, Osteopontin, Total ALP), and serum levels of some inflammatory and oxidative factors (TAC, SOD, MDA, TNF-α, HS-CRP, IL-6)
General information
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Reason for update
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Hi, Hereby, the study protocol in the measuring part of serum level "CTX","BSAP","P1NP" was changed to "osteopontin" and "alkaline phosphatase (ALP)" as alternatives due to high cost and impossibility of assaying. Please agree.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20131009014957N4
Registration date:
2018-07-16, 1397/04/25
Registration timing:
prospective
Last update:
2023-01-21, 1401/11/01
Update count:
3
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Registration date
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2018-07-16, 1397/04/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-16, 1397/05/25
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Expected recruitment end date
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2019-12-16, 1398/09/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Curcumin, Nigella Sativa, and Curcumin-Nigella Sativa on cellular- molecular and clinical outcomes related to primary osteoporosis among postmenopausal women: A triple blind randomized controlled trial
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Public title
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The effect of Curcumin, Nigella Sativa, and Curcumin-Nigella Sativa on outcomes related to primary osteoporosis among postmenopausal women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Postmenopausal women aged 50 to 65 years
Ability to self-care
Resident of Tabriz city
Menstrual cessation for at least 12 consecutive months
Low bone density (T-score <-2.5) in lumbar spine or hip (total and femoral neck)
No fracture history
The ability to communicate verbally for answering questions
Exclusion criteria:
T-score≤-4 in lumbar spine or T-score≤-3.5 in femoral neck bone
Renal failure and diseases
Bone disease other than osteoporosis
The use of medications that affect bone metabolism, including intravenous bisphosphonate over the past 5 years, oral bisphosphonate use in the last 6 months, cumulative oral bisphosphonate use for more than 3 years, or more than 1 month between 6-12 months before the study, Use of parathyroid hormone analogues over the past 12 months or strontium, fluoride or cathepsin k inhibitor at any time, use of hormonal medications or corticosteroids during the study or within 3 months before (or more).
Chronic liver disease
Other systemic diseases, such as diabetes, gastrointestinal disorders, and endocrine disorders
Mental illness, as reported by the woman
The malignancy, as reported by the woman
Taking anti-coagulants, and coagulation disorders
Stomach ulcers and gallstones
The levels of 25-hydroxyvitamin D less than 20ng/ ml
Current Hypercalcemia or hypocalcemia
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Age
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From 50 years old to 65 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Women with primary osteoporosis were randomly assigned into four groups recieving: 1) Nigella Sativa capsule and curcumin placebo; 2) curcumin capsule and Nigella Sativa placebo; 3) Nigella Sativa and curcumin capsule ; or 4) placebo capsules of Nigella Sativa and curcumin. Allocation sequence will be determined using random blocking of blocks 4 and 8 in RAS software (Random Allocation Software) using a 1: 1: 1: 1 assignment ratio. To conceal the allocation, the medications will be placed inside a consecutively numbered sealed opaque envelopes. Preparation of envelopes and sequence generation will be done by a person not involved in participant recruitment or data collection.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The medications and their placebo will be prepared by the pharmaceutical company in identical shape, color and smell. Investigators, health care providers, outcome assessors, and statistical analyst will be blinded.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-14, 1397/02/24
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Ethics committee reference number
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IR.TBZMED.REC.1397.131
Health conditions studied
1
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Description of health condition studied
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Postmenopausal osteoporosis
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ICD-10 code
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M81
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ICD-10 code description
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Osteoporosis without current pathological fracture
Primary outcomes
1
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Description
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Bone mineral density
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Timepoint
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At the baseline (before intervention) and just after completion of the intervention (6 months after beginning the intervention )
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Method of measurement
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Dual-energy X-ray absorptiometry (DXA)
2
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Description
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Serum levels of bone turnover markers (Osteocalcin، Osteopontin, Total Alkaline Phosphatase)
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Timepoint
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At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention )
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Method of measurement
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Using the ELISA method
3
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Description
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Serum levels of some inflammatory factors (TNF-α, hs-CRP, IL-6)
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Timepoint
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At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention )
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Method of measurement
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Using calorie meter and ELISA method
Secondary outcomes
1
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Description
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Serum levels of osteoporosis MicroRNA (miR422a، miR-133a، miR-21 و miR-503)
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Timepoint
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At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention )
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Method of measurement
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Using the Real-Time PCR method
2
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Description
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Quality of life score
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Timepoint
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At the baseline (before intervention) and 1,3, and 6 months after beginning intervention
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Method of measurement
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Using the MENQOL questionnaire
3
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Description
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Body composition analysis score (PBF, MBF, SLM, LBM, VFM, TBW, Mineral)
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Timepoint
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At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention)
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Method of measurement
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Body Composition Analyzer
4
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Description
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The 10-year probability of fracture
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Timepoint
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At the baseline (before intervention) and completion of intervention (6 months after beginning of study)
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Method of measurement
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Fracture Risk Assessment Tool (FRAX)
5
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Description
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Serum levels of some oxidative stress indices (TAC, SOD, MDA)
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Timepoint
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At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention )
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Method of measurement
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Using Spectrophotometer and ELISA method
6
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Description
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Serum levels of Insulin-like Growth Factor-I and binding proteins (TAC, SOD, MDA)
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Timepoint
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At the baseline (before intervention) and completion of intervention (6 months after beginning of study)
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Method of measurement
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Using Spectrophotometer and ELISA method
7
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Description
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Lipid profile
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Timepoint
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At the baseline (before the intervention) and completion of the intervention (6 months after the beginning of the study)
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Method of measurement
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biochemical methods
8
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Description
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Glycemic control indices
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Timepoint
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At the baseline (before intervention) and completion of the intervention (6 months after the beginning of the study
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Method of measurement
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biochemical methods
9
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Description
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Serum 17-β estradiol
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Timepoint
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At the baseline (before intervention) and completion of the intervention (6 months after the beginning of the study
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Method of measurement
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Using ELISA method
Intervention groups
1
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Description
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Intervention group 1: One Nigella Sativa oil soft-gel capsule 1000 mg once a day prepared by Baryj Essence pharmaceutical company and one Curcumin placebo capsule containing 80 mg carboxymethyl cellulose once a day produced by Exir Nano Sina company, orally by for 6 months,
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: One Curcumin soft-gel capsule containing 80 mg Curcumin as nanomicelle once a day prepared by Exir Nano Sina company, and one Nigella Sativa placebo capsule containing 1000 mg carboxymethyl cellulose once a day produced by Baryj Essence pharmaceutical company, orally for 6 months.
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Category
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Treatment - Drugs
3
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Description
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Intervention group 3: One Nigella Sativa oil soft-gel capsule 1000 mg once a day prepared by Baryj Essence pharmaceutical company and one Curcumin soft-gel capsule containing 80 mg Curcumin as nanomicelle once a day prepared by Exir Nano Sina company, orally for 6 months.
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Category
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Treatment - Drugs
4
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Description
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Control group: One Nigella Sativa placebo soft-gel capsule containing 1000 mg carboxymethyl cellulose once a day prepared by Baryj Essence pharmaceutical companyand one Curcumin placebo capsule containing 80 mg carboxymethyl cellulose once a day prepared by Exir Nano Sina company, orally for 6 months.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis).
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When the data will become available and for how long
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starting immediately after publication
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To whom data/document is available
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Data will be available to researchers as well as to journals.
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Under which criteria data/document could be used
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The data will be available to researchers upon request and submission of a proposal to perform meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journals for checking.
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From where data/document is obtainable
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Refer to the email address (farshbafa@tbzmed.ac.ir).
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What processes are involved for a request to access data/document
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The requests will be sent by email and data will be available within a week.
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Comments
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