Vitamin D DeficiencyVDNCT01807845
Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment.
A study testing enriched skimmilk with VD and Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80 in people with Vitamin D Deficiency, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Background: Vitamin D3 (VD) is an oil soluble vitamin formed in the skin during exposure to UV light. It is essential for bone and calcium metabolism, insulin reactivity, immune system etc. The dietary sources of VD are scarce, and insufficient. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- enriched skimmilk with VD and Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Dec 2013
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers . adults aged 18 - 65
Who cannot join
- Intestinal malabsorption, lactose intolerance, medical illness (e.g. liver disease, kidney disease, or diabetes), hypercalcemia, excessive alcohol use, pregnancy, use of medications known to interfere with vitamin D metabolism e.g. anticonvulsants, barbiturates, or steroids), granulomatous disease, use of vitamin D supplements, potential for significant sun exposure (e.g., travel to a sunny vacation site or use of tanning beds) within the month prior to, or during, the study. -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam-Health Care Campus
Haifa, 31096
YOAV LIVNEY, MD, 972 778874225, livney@technion.ac.il
SOFIA ISH-SHALOM, MD
About this study
Background: Vitamin D3 (VD) is an oil soluble vitamin formed in the skin during exposure to UV light. It is essential for bone and calcium metabolism, insulin reactivity, immune system etc. The dietary sources of VD are scarce, and insufficient. Epidemiological studies link proper VD status with lower risks of bone fracture, hypertension, diabetes, cancer and more. VD deficiency is widespread, mainly due to avoidance of sun exposure due to fear of melanoma. Therefore there is an urgent need to enrich staple foods \& beverages with VD, to prevent deficiency.
A novel technology was developed , for nanoencapsulating VD within casein micelles (CM) (natural milk protein nanoparticles). Previously we have found that the bioavailability of VD in CM in 1% fat milk was similar to that in an aqueous dietary supplement based on a synthetic emulsifier- Tween 80- which is sometimes used by the industry to add VD into milk.
Read more
The main research question studied in the current project is: how will the bioavailability of VD be affected by its delivery in CM compared to its delivery using Tween 80 in a fat free milk product, like nonfat yogurt.
Hypothesis: The open molecular structure of caseins, which evolved to be easily digestible, may facilitate the bioavailability of VD nanoencapsulated in CM, so that it will not be less than that in Tween 80, which is considered to be good. CM are particularly useful for oil-soluble micronutrient delivery in non-fat products. The most widely consumed nonfat milk product is 0% fat yoghurt, chosen it for this study.
Methods: Yoghurts will be made from 3 milk formulations:
- Skim milk (0% fat) enriched with 50,000 international units (IU) VD in 150 gr product, in CM.
- Skim milk with same dosage of VD, emulsified with Tween 80.
- Placebo: skim milk without added VD. 90 healthy adults, aged 18-65, having passed a medical qualification examination, will be randomly assigned to 3 groups. Following over-night fasting they will each consume a 150 gr yoghurt sample as detailed above, and be requested to fast 2 more hours. Blood will be sampled before yoghurt consumption, and after 1, 7 and 14 days following consumption. Blood-serum level of 25(OH)D (the form of VD used as a status indicator in routine blood tests), by chemiluminescence immunoassay (CMIA).
Expected findings: The bioavailability of VD in CM will not be lower than that in Tween 80, in 0% fat yoghurt.
Significance of the study: With the widespread VD deficiency, decreased fat consumption and rising demand for using only natural ingredients there is great importance in delivery of VD and other fat-soluble micronutrients in protein-based delivery systems, like CM, instead of using synthetic emulsifiers, and it is imperative to assure the bioavailability is not compromised by this dramatic change.
CM solubilize VD and help uniformly distribute it in aqueous products and protect it against heat, oxidation and UV.
- Conditions
- Vitamin D Deficiency
- Being tested
- enriched skimmilk with VD, Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80, Placebo: un-enriched skimmilk.
- Keywords
- Casein micelles, vitamin D3 (cholecalciferol), Bioavailability, Nanoencapsulation, Nutrition
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enriched skimmilk with VDDietary supplement
enriched skimmilk with VD
Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80Dietary supplement
Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80
Placebo: un-enriched skimmilk.Dietary supplement
Placebo: un-enriched skimmilk
| Study group | Role | What they receive |
|---|---|---|
| Skimmilk VD will be emulsified using Tween 80 | Active comparator | Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80; Receives: Dietary Supplement: Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80 |
| Placebo: un-enriched skimmilk. | Placebo comparator | Placebo: un-enriched skimmilk. Receives: Dietary Supplement: Placebo: un-enriched skimmilk. |
| enriched skimmilk with VD | Active comparator | enriched skimmilk with VD Receives: Dietary Supplement: enriched skimmilk with VD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D level
Measured: 0, 1 day, 7 days, 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807845
- Sponsor's protocol ID
- No. 1-Version 1.
- Acronym
- VD
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2013
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment.
- ClinicalTrials.gov ID
- NCT01807845
- Acronym / sponsor ID
- VD / No. 1-Version 1.
- Conditions
- Vitamin D Deficiency
- Keywords
- Casein micelles, vitamin D3 (cholecalciferol), Bioavailability, Nanoencapsulation, Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Vitamin D3 (VD) is an oil soluble vitamin formed in the skin during exposure to UV light. It is essential for bone and calcium metabolism, insulin reactivity, immune system etc. The dietary sources of VD are scarce, and insufficient. Epidemiological studies link proper VD status with lower risks of bone fracture, hypertension, diabetes, cancer and more. VD deficiency is widespread, mainly due to avoidance of sun exposure due to fear of melanoma. Therefore there is an urgent need to enrich staple foods \& beverages with VD, to prevent deficiency.
A novel technology was developed , for nanoencapsulating VD within casein micelles (CM) (natural milk protein nanoparticles). Previously we have found that the bioavailability of VD in CM in 1% fat milk was similar to that in an aqueous dietary supplement based on a synthetic emulsifier- Tween 80- which is sometimes used by the industry to add VD into milk.
The main research question studied in the current project is: how will the bioavailability of VD be affected by its delivery in CM compared to its delivery using Tween 80 in a fat free milk product, like nonfat yogurt.
Hypothesis: The open molecular structure of caseins, which evolved to be easily digestible, may facilitate the bioavailability of VD nanoencapsulated in CM, so that it will not be less than that in Tween 80, which is considered to be good. CM are particularly useful for oil-soluble micronutrient delivery in non-fat products. The most widely consumed nonfat milk product is 0% fat yoghurt, chosen it for this study.
Methods: Yoghurts will be made from 3 milk formulations:
- Skim milk (0% fat) enriched with 50,000 international units (IU) VD in 150 gr product, in CM.
- Skim milk with same dosage of VD, emulsified with Tween 80.
- Placebo: skim milk without added VD. 90 healthy adults, aged 18-65, having passed a medical qualification examination, will be randomly assigned to 3 groups. Following over-night fasting they will each consume a 150 gr yoghurt sample as detailed above, and be requested to fast 2 more hours. Blood will be sampled before yoghurt consumption, and after 1, 7 and 14 days following consumption. Blood-serum level of 25(OH)D (the form of VD used as a status indicator in routine blood tests), by chemiluminescence immunoassay (CMIA).
Expected findings: The bioavailability of VD in CM will not be lower than that in Tween 80, in 0% fat yoghurt.
Significance of the study: With the widespread VD deficiency, decreased fat consumption and rising demand for using only natural ingredients there is great importance in delivery of VD and other fat-soluble micronutrients in protein-based delivery systems, like CM, instead of using synthetic emulsifiers, and it is imperative to assure the bioavailability is not compromised by this dramatic change.
CM solubilize VD and help uniformly distribute it in aqueous products and protect it against heat, oxidation and UV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skimmilk VD will be emulsified using Tween 80 | Active comparator | Dietary Supplement: Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80; |
| Placebo: un-enriched skimmilk. | Placebo comparator | Dietary Supplement: Placebo: un-enriched skimmilk.Placebo: un-enriched skimmilk. |
| enriched skimmilk with VD | Active comparator | Dietary Supplement: enriched skimmilk with VDenriched skimmilk with VD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers . adults aged 18 - 65
Key exclusion criteria (1 listed)
- Intestinal malabsorption, lactose intolerance, medical illness (e.g. liver disease, kidney disease, or diabetes), hypercalcemia, excessive alcohol use, pregnancy, use of medications known to interfere with vitamin D metabolism e.g. anticonvulsants, barbiturates, or steroids), granulomatous disease, use of vitamin D supplements, potential for significant sun exposure (e.g., travel to a sunny vacation site or use of tanning beds) within the month prior to, or during, the study. -
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 |
|---|---|---|
| enriched skimmilk with VDenriched skimmilk with VD | Dietary supplement | enriched skimmilk with VD |
| Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80 | Dietary supplement | Skimmilk VD will be emulsified using Tween 80 |
| Placebo: un-enriched skimmilk.Placebo: un-enriched skimmilk | Dietary supplement | Placebo: un-enriched skimmilk. |
Primary outcome
Serum 25(OH)D level
Time frame: 0, 1 day, 7 days, 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enriched skimmilk with VD and Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80 in people with Vitamin D Deficiency, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Mar 2013. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SOFIA ISH-SHALOM, MD (972-4-8543033, s_ish_shalom@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25(OH)D level (time frame: 0, 1 day, 7 days, 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2013.