Last updated: 05/14/2019 09:57:21
To investigate the impact of a nutritional supplement on Bone turnover markers in Indian healthy premenopausal women (25- 45 years) after 6 months of intervention
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Impact of a Nutritional supplement on Bone turnover markers in Indian healthy premenopausal women (25-45 yrs; inclusive) after 6 months of intervention: a randomised double blind controlled trial
Trial description: To investigate the effect of nutritional supplement on bone turnover markers (which are sensitive and respond quickly to nutrition or drug intervention) in Indian healthy premenopausal women after 6 months of intervention.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from baseline in serum C-telopeptide of type 1 collagen (s-CTX-1)
Timeframe: At 6 months
Change from baseline in the ratio of carboxylated (c-OC) to under-carboxylated Osteocalcin (uc-OC)
Timeframe: At 6 months
Secondary outcomes:
Change from baseline in s-CTX-1
Timeframe: At 3 months
Change from baseline in the ratio of c-oc to uc-OC
Timeframe: At 3 months
Change from baseline in Urinary CTX-1
Timeframe: At 3 and 6 months
Change from baseline in serum N-terminal telopeptide of type 1 collagen (s-NTX-1)
Timeframe: At 3 and 6 months
Change from baseline in serum procollagen type 1 N-terminal propeptide (s-P1NP)
Timeframe: At 3 and 6 months
Change from baseline in bone specific alkaline phosphatase (BSAP)
Timeframe: At 3 and 6 months
Change from baseline in Serum Parathyroid Hormone (s-PTH)
Timeframe: At 3 and 6 months
Change from baseline in urinary calcium
Timeframe: At 3 and 6 months
Change from baseline in serum calcium
Timeframe: At 3 and 6 months
Change from baseline in serum phosphorus
Timeframe: At 3 and 6 months
Change from baseline in total alkaline phosphatase (ALP)
Timeframe: At 3 and 6 months
Change from baseline in 25-hydroxycholecalciferol (25 OH D3)
Timeframe: At 3 and 6 months
Change from baseline in serum selenium (Se)
Timeframe: At 3 and 6 months
Change from baseline in plasma Zinc (Zn)
Timeframe: At 3 and 6 months
Change from baseline in serum folic acid
Timeframe: At 3 and 6 months
Change from baseline in Plasma Vitamin B6
Timeframe: At 3 and 6 months
Change from baseline in serum Vitamin B12
Timeframe: At 3 and 6 months
Interventions:
Dietary supplement: Fortified Beverage Powder
Dietary supplement: Non fortified beverage Powder
Enrollment:
114
Observational study model:
Not applicable
Primary completion date:
2018-16-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Growth and Development
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2017 to January 2018
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female
Age
25 - 45 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Female Participants.
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or Women who have a positive urine pregnancy test.
- Women who have attained physiological menopause defined as those who have not had a menstrual period for consecutive 12 months.
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Female Participants.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- BMI between 18.0-30 (kg/m2, Kilograms Per Meter Square) inclusive.
- Women who understand, willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or Women who have a positive urine pregnancy test.
- Women who have attained physiological menopause defined as those who have not had a menstrual period for consecutive 12 months.
- Women who are breast-feeding.
- Current (within 14 days of the start of the study) or regular use of any prescription, over the counter (OTC), vitamin supplements herbal medicine unless the medication has been approved by the study physician.
- Treatment with bisphosphonates (any dose within the previous 2 years) or other medications known to affect bone (within the previous 6 months).
- History of metabolic bone disease.
- Any hormonal disorders or disturbances.
- Bone fracture in last 12 months.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participant is lactose intolerant.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last 1 year) of alcohol or other substance abuse.
- More than 2 Units of alcohol per day
- Smokers
- Currently taking any other health food drinks/beverages or supplements (including nutritional supplements e.g. multivitamins and/or herbal supplements e.g. ginkgo) or has been on supplements within a month prior to study start.
- Women who used medication known to influence bone mass and the use of calcium, vitamin D, and multivitamin supplements on a regular basis were stopped 2 months before the onset of the trial.
- An employee of the sponsor or the study site or members of their immediate family.
- Ongoing conditions known to cause abnormalities of calcium metabolism or skeletal health, malabsorption syndromes (such as coeliac or Crohn’s disease), hyperthyroidism, hyperparathyroidism, hypo- or hypercalcaemia, osteomalacia, Paget’s disease, and diabetes.
- Fracture in the past 12 months.
- Known chronic kidney disease or alcoholism.
- Obesity women ( Body Mass Index, BMI>30) and Thinness i.e. BMI<18 kg/m2
- Severely anemic (Hemoglobin, Hb<8 g/dl, Grams Per Decilitre).
- Undertaking excessive exercise (>2 strenuous* exercise sessions per week)
- Contraceptive injections within the previous year.
- Known histories of surgeries such as bilateral oophrectomy (surgical removal of ovaries)
- Diagnosed hypogondal states such as Turner syndrome, Klinfelter syndrome, Kallman
- syndrome, anorexia nervosa, hypothalamic amenorrhea or hyperprolactinemia
- Hemotological disorders e.g. Hemophilia, Leukemia and lymphomas monoclonal multiple myeloma, sickle cell disease, Thalassemia etc.
- Rheumatological and autoimmune disorders such as ankylosing spondylitis, rheumatoid arthritis, systemic lupus etc.
- Miscellaneous conditions and diseases such as Human Immunodeficiency Virus/acquired immunodeficiency syndrome (HIV/AIDS), alcoholism, amyloidosis, chronic metabolic acidosis, Chronic Obstructive Pulmonary Disease (COPD), congestive heart failure, depression etc.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2018-16-01
Actual study completion date
2018-16-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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