Growth and DevelopmentNCT03155269

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

A study testing Fortified Beverage Powder and Non fortified beverage Powder in people with Growth and Development, run by GlaxoSmithKline at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 25 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Growth and Development
What is being tested?: Fortified Beverage Powder and Non fortified beverage Powder
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteIndia
Study dates: 25 May 2017to 16 Jan 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 31Show fewer

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 locations and contacts

1 site in 1 country.

India1 site

GSK Investigational Site
Pune, 411001

Other trials in India

About this study

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

Read the detailed description

This will be a double blind, single-center, randomized-controlled trial testing the effect of fortified beverage on bone turnover markers as compared to placebo control in 25-45 years old premenopausal women. The study will consist of two groups: Group 1 (Test) - Protein rich beverage powder fortified with MMN and Group 2 (control) - Low protein non-fortified iso-caloric beverage powder.

Conditions: Growth and Development
Being tested: Fortified Beverage Powder, Non fortified beverage Powder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fortified Beverage PowderDietary supplement
The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.
Non fortified beverage PowderDietary supplement
The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Non fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.

Study groups in NCT03155269
Study group	Role	What they receive
Group 1- Protein rich beverage powder fortified with MMN	Experimental	Participants will be administered orally two doses of cereal based fortified beverage (30 grams powder made up in 200 milliliter (mL) water) daily in the morning and evening for 6 months. Receives: Dietary Supplement: Fortified Beverage Powder
Group 2 -Low protein non-fortified iso-caloric beverage powder	Other	Participants will be administered orally two doses (in morning and evening) of low protein non fortified isocaloric beverage (30 grams powder made up in 200 mL water) daily for 6 months. Receives: Dietary Supplement: Non fortified beverage Powder

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months
s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health.
Measured: At baseline and at 6 months
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months
c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health.
Measured: At baseline and 6 months

Secondary outcomes (17)

Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months
s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health.
Measured: At baseline and at 3 months
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months
c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health.
Measured: At baseline and at 3 months
Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months
Urinary-CTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. CTX-1 urine levels were analysed using biochemical tests from the samples stored. Decreased urinary CTX-1 is associated with improved bone health.
Measured: At baseline, at 3 and 6 months
Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months
NTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. NTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-NTX-1 is associated with improved bone health. The unit of measurement is nanomole bone collagen equivalent (NM BCE).
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months
P1NP is a bone formation surrogate marker which is used to assess the bone health being the most abundant protein of bone matrix. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. P1NP serum was analysed using biochemical tests from the samples stored. Increased s-P1NP is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months
BSAP is a bone formation surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. BSAP serum was analysed using biochemical tests from the samples stored. Increased s-BSAP is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months
PTH is used to compare calcium concentration status which defines the healthy bones. Intact PTH is the biologically active form and is secreted when the calcium level is low. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. PTH serum was analysed using biochemical tests from the samples stored. Decreased s-PTH is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Urinary Calcium at 3 Months and 6 Months
Urinary calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. Urinary calcium was analysed using biochemical tests from the samples stored. Decreased urinary calcium is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Serum Calcium at 3 Months and 6 Months
Serum calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum calcium was analysed using biochemical tests from the samples stored. Increased serum calcium is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Serum Phosphorus at 3 Months and 6 Months
Serum phosphorus is a diagnostic marker for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum phosphorus was analysed using biochemical tests from the samples stored. Increased serum phosphorus is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months
ALP is a diagnostic marker of which is used to assess bone mineral density for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum ALP was analysed using biochemical tests from the samples stored. Increased serum ALP is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months
Serum vitamin-D3 is used to analyse the status of vitamin-D profile which is necessary for healthy bones. The marker used for analyzing serum vitamin-D3 was 25 OH D3. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-D3 was analysed using biochemical tests from the samples stored. Increased serum vitamin-D3 is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months
Serum Se is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum Se was analysed using biochemical tests from the samples stored. Increased serum Se is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months
Plasma Zn is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased plasma Zn is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months
Serum folic acid (folate) is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased serum folate is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months
Plasma vitamin-B6 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma vitamin-B6 was analysed using biochemical tests from the samples stored. Increased plasma vitamin-B6 is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months
Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months
Serum vitamin-B12 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-B12 was analysed using biochemical tests from the samples stored. Increased serum vitamin-B12 is associated with improved bone health.
Measured: At baseline, at 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 201716 Jan 2018

First posted16 May 2017
Study start25 May 2017
Primary completion16 Jan 2018
Study completion16 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Growth and DevelopmentStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03155269
Sponsor's protocol ID: 207192
Status last verified: Jan 2019
First submitted: 15 May 2017
Last updated: 12 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03155269
Acronym / sponsor ID: 207192
Conditions: Growth and Development
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 25 May 2017 (actual)
Primary completion: 16 Jan 2018 (actual)
Study completion: 16 Jan 2018 (actual)
First posted: 16 May 2017 (actual)
Results: Posted 12 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1- Protein rich beverage powder fortified with MMN	Experimental	Dietary Supplement: Fortified Beverage PowderParticipants will be administered orally two doses of cereal based fortified beverage (30 grams powder made up in 200 milliliter (mL) water) daily in the morning and evening for 6 months.
Group 2 -Low protein non-fortified iso-caloric beverage powder	Other	Dietary Supplement: Non fortified beverage PowderParticipants will be administered orally two doses (in morning and evening) of low protein non fortified isocaloric beverage (30 grams powder made up in 200 mL water) daily for 6 months.

Who may qualify

Ages: 25 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (31 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fortified Beverage PowderThe tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.	Dietary supplement	Group 1- Protein rich beverage powder fortified with MMN
Non fortified beverage PowderThe tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Non fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.	Dietary supplement	Group 2 -Low protein non-fortified iso-caloric beverage powder

Primary outcome

Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months
Time frame: At baseline and at 6 months
s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health.
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months
Time frame: At baseline and 6 months
c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health.

17 secondary outcomes

Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months
Time frame: At baseline and at 3 months
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months
Time frame: At baseline and at 3 months
Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months
Time frame: At baseline, at 3 and 6 months
Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Urinary Calcium at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Serum Calcium at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Serum Phosphorus at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months
Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months
Time frame: At baseline, at 3 months and 6 months

Results and safety

Results posted to the registry on 12 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product	57	52
Reference Product	57	50

Primary outcome: Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months

Time frame: At baseline and at 6 months. Mean (Standard Deviation). Unit: Micrograms per litres (mcg/L)

Measure	Test Product n = 52	Reference Product n = 50
At Baseline	0.4440 (0.11932)	0.4410 (0.16213)
At 6 months	0.2828 (0.14218)	0.3245 (0.16755)
Change from baseline at 6 months	-0.1612 (0.15011)	-0.1165 (0.16574)

Test Product vs Reference Product: Mean Difference (Final Values): -0.0423 (97.5% CI -0.1057 to 0.0211), p = 0.1324, ANCOVA

Population analysed: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.

Primary outcome: Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months

Time frame: At baseline and 6 months. Mean (Standard Deviation). Unit: Ratio

Measure	Test Product n = 52	Reference Product n = 50
At baseline	1.208 (0.7573)	1.138 (0.6747)
At 6 months	1.492 (0.6666)	1.251 (0.4858)
Change from baseline at 6 months	0.284 (0.8961)	0.113 (0.7160)

Test Product vs Reference Product: Mean Difference (Final Values): 0.229 (97.5% CI -0.030 to 0.489), p = 0.0469, ANCOVA

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: 180 days +/- 7. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product	0 of 57 (0%)	19 of 57 (33.3%)	0 of 57
Reference Product	0 of 57 (0%)	19 of 57 (33.3%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

GSK Clinical Trials study director

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fortified Beverage Powder and Non fortified beverage Powder in people with Growth and Development, run by GlaxoSmithKline at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months (time frame: At baseline and at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.