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MenopauseNCT02534064

Effect of Consumption of Yogurt Fortified in Calcium and Vit. D on Circulating Levels of 25OHD in Postmenopausal Women

A study testing CALIN+ in people with Menopause and Vitamin D Deficiency, run by Yoplait France SAS at 1 site in France.

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

The purpose of this study is to evaluate the effect of daily consumption of one or two CALIN+ pot(s) versus no intake of product, after 4, 8, 12 and 16 weeks, on the evolution of the serum concentration of 25-hydroxy vitamin D (25OHD) (D2 + D3) in postmenopausal women. Read more about this study

Who is it for?
Ages 55 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Menopause, Vitamin D Deficiency
What is being tested?
CALIN+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteFrance
Study dates
Oct 2014to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

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 55 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female subject, aged between 55 and 75 years inclusive.
  • Menopausal female subject for more than 5 years.
  • Non smoker or smoker less than 5 cigarettes a day
  • Body Mass Index (BMI) between 18 and 28 kg/m² inclusive.
  • Subject with a serum 25-hydroxyvitamin D2 + D3 between 10 and 30 ng/mL corresponding to a vitamin D insufficiency.
  • Subject with a Mini Nutritional Assessment (MNA) > 20.
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  • Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
  • Normal blood pressure (BP) and heart rate (HR) at the screening visit after 10 minutes in supine position:
  • 95 mmHg ≤ systolic blood pressure (SBP) ≤ 160 mmHg,
  • 50 mmHg ≤ diastolic blood pressure (DBP) ≤ 95 mmHg,
  • 40 bpm ≤ HR (heart rate) ≤ 80 bpm.
  • Subject with normal dietary habits (no vegetarian, lactose intolerant, gluten-free subject).
  • Having given a written informed consent prior to selection.
  • Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Who cannot join

  • Subject who have taken any form of vitamin D supplementation in the 6 months preceding the study, including through fortified food (milk, dairy products, oil and tofu) or food supplements.
  • Subject who consumed more than 3 dairy products per day.
  • Functional impotence.
  • Concomitant bone disease or affecting mineral metabolism, in whatever form.
  • History of bone fracture in the previous year.
  • Presence of a primary hyperparathyroidism, chronic gastrointestinal disease or patent hepatic and/or renal impairment or a progressive severe disease.
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  • Type 1 diabetic subject.
  • Subject with eating disorder.
  • Subject with a treatment which can interfere with the study purpose at the moment of recruitment or 6 months before (see section 5.6)
  • Significant allergies or food intolerance.
  • Subject who cannot be contacted in case of emergency.
  • History or presence of drug or alcohol abuse (alcohol consumption > 5 glasses / day).
  • Medical and surgical history which, in the judgment of the Investigator, is not compatible with this study.
  • Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, or has poor mental development.
  • Blood donation within two months before the study beginning.
  • Subject in the exclusion period of a previous study or subject who refuse to be on the "Fichier National des Volontaires Sains".
  • Subject who refuse to sign the Informed Consent Form.
  • Participation to another study within 3 months prior the study beginning.
  • Subject under administrative or legal supervision.
  • Subject who are deprived of their liberty by judicial of administration decision.
  • Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Eurofins Optimed

    Gières, 38610

Other trials in France

About this study

Official title: Effect of the Consumption of Yogurt Fortified in Calcium and Vitamin D on the Circulating Levels of 25OHD in Postmenopausal Women

The purpose of this study is to evaluate the effect of daily consumption of one or two CALIN+ pot(s) versus no intake of product, after 4, 8, 12 and 16 weeks, on the evolution of the serum concentration of 25-hydroxy vitamin D (25OHD) (D2 + D3) in postmenopausal women.

Read the detailed description

The active form of vitamin D is produced by skin when it is exposed to ultraviolet-B (UVB) rays. However, because of our sedentary lifestyle and to the low sun exposure during winter, the vitamin D status is most frequently deficient. Hence the consumption of enriched food could be an efficient strategy to improve vitamin D status.

The current recommendation for vitamin D intake is 20 µg per day for adults (19-50 yo) and between 25 and 37.5 µg per day for people over 50 years old according to the French National Medicine Academy. However, the recommended daily allowance (RDA) in France for vitamin D is limited to 5 µg corresponding to the maximum enrichment allowed in a food product. The current study is designed to evaluate if a daily consumption of two CALIN+ yogurts enriched with 5µg of vitamin D is sufficient to improve the vitamin D status in postmenopausal women.

Being tested
CALIN+
Keywords
Menopause, Osteoporosis, Hip fractures, vitamin D deficiency
Medical subject headings
Vitamin D Deficiency, Osteoporosis, Hip Fractures

What participants receive

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

  • CALIN+Dietary supplement

    Consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.

  • CALIN+Dietary supplement

    Consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product intake during 8 weeks.

Study groups in NCT02534064
Study groupRoleWhat they receive
Group A: 2 yogurtsExperimentalconsumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.
Receives: Dietary Supplement: CALIN+
Group B: 1 yogurtExperimentalconsumption of 1 CALIN+ pot per day during 16 weeks and follow up without product during 8 weeks.
Receives: Dietary Supplement: CALIN+
Group C: No yogurtNo interventionno changes in dietary habits during 24 weeks.

What is being measured

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

  1. Change of serum 25OHD (D2 + D3) concentration over the 16 weeks

    Measured: serum 25OHD (D2 + D3) concentration will be evaluated at 4, 8, 12 and 16 weeks

Secondary outcomes (19)

  1. Serum ParaThyroid Hormone (PTH) level

    Serum (ParaThyroid Hormone) PTH level

    Measured: Evolution after 16 weeks consumption period

  2. Serum calcium level

    Serum calcium level

    Measured: Evolution after 16 weeks consumption period

  3. Serum 25OHD (D2 + D3) level

    Serum 25OHD (D2 + D3) level

    Measured: Evolution after 16 weeks consumption period

  4. Diastolic / systolic blood pressures (mm/Hg)

    Diastolic / systolic blood pressures

    Measured: Evolution after 16 weeks consumption period

  5. Weight (kg)

    Weight (kg)

    Measured: Evolution after 16 weeks consumption period

  6. Waist circumference (cm)

    Waist circumference (com)

    Measured: Evolution after 16 weeks consumption period

  7. Rate constant

    Rate constant

    Measured: over two months

  8. Serum 25OHD (D2 + D3) level

    Serum 25OHD (D2 + D3) level

    Measured: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)

  9. Serum ParaThyroid Hormone (PTH) level

    Serum ParaThyroid Hormone (PTH) level

    Measured: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)

  10. Serum calcium level

    Serum calcium level

    Measured: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)

  11. Diastolic/systolic blood pressures (mm/Hg)

    Diastolic/systolic blood pressures (mm/Hg)

    Measured: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)

  12. Weight (kg)

    Weight (kg)

    Measured: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)

  13. Waist circumference (cm)

    Waist circumference (cm)

    Measured: Evolution over 8 weeks consumption period for women included in study during winter (before March 1, 2015)

  14. Serum levels of 25OHD (D2 + D3),

    Serum levels of 25OHD (D2 + D3),

    Measured: Evolution over the 2 months follow up period

  15. Serum ParaThyroid Hormone (PTH) level

    Serum ParaThyroid Hormone (PTH) level

    Measured: Evolution over the 2 months follow up period

  16. Assessment of sun exposure and dietary vitamin D intake using the Garabedian questionnaire

    Assessment of sun exposure and dietary vitamin D intake using the Garabedian questionnaire

    Measured: 4 months and 6 months

  17. Assessment of calcium intake using a simplified calcium questionnaire

    Assessment of calcium intake using a simplified calcium questionnaire

    Measured: over the 16-week consumption period and over the first 8 weeks consumption for women included in the study during the winter season, i.e. before March 1, 2015.

  18. Compliance of CALIN+ consumption reported in diary

    Number of consumed yogurt per day

    Measured: up to 20 weeks

  19. Acceptability of CALIN+ consumption by questionnaire

    Change from baseline in acceptability score (0: do not agree at all; 10: agree completely)

    Measured: up to 20 weeks

Timeline

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

  1. First posted27 Aug 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02534064
Sponsor's protocol ID
CATWIN2107
Status last verified
Oct 2015
First submitted
19 Aug 2015
Last updated
16 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing CALIN+ in people with Menopause and Vitamin D Deficiency, run by Yoplait France SAS at 1 site in France.

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 14 inclusion and 21 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 16 Oct 2015. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of serum 25OHD (D2 + D3) concentration over the 16 weeks (time frame: serum 25OHD (D2 + D3) concentration will be evaluated at 4, 8, 12 and 16 weeks). 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 NCT02534064.

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 16 Oct 2015.

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