NCT02457247

Brief Summary

The purpose of this study is to compare the preference of Calcichew D3 500/400 (containing 500 mg calcium and 400 IU of vitamin D) with Adcal-D3 600/400 (containing 600 mg of calcium and 400 IU of vitamin D) in Test Group 1, and to compare Calcichew D3 500/800 (containing 500 mg calcium and 800 IU vitamin D) with Kalcipos-D 500/800 (containing 500 mg of calcium and 800 IU of vitamin D) in Test Group 2.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 25, 2016

Completed
Last Updated

October 25, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

May 27, 2015

Results QC Date

June 1, 2016

Last Update Submit

August 29, 2016

Conditions

Calcium and Vitamin D Deficiencies

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Preference for Each Treatment Within Each Test Group

    Preference was assessed by a 3 box questionnaire. Participants checked off one of the boxes: I prefer the first product that was tested, I prefer the second product that was tested or I have no preference. Test Group 1 (United Kingdom): Calcichew D3 is 500/400 and the comparator is Adcal-D3. Test Group 2 (Germany): Calcichew D3 is 500/800 and the comparator is Kalcipos-D.

    Day 28

Secondary Outcomes (2)

  • Product Acceptability After Each 14 Day Dosing Period Within Each Test Group

    Day 14 and Day 28

  • Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group

    Day 1 to Day 28

Study Arms (4)

Test Group 1: Sequence AB

EXPERIMENTAL

Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) \[A\], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) \[B\], chewable tablets, orally, twice, daily, on Days 15 through 28.

Drug: Calcichew D3Drug: Adcal-D3

Test Group 1: Sequence BA

EXPERIMENTAL

Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.

Drug: Calcichew D3Drug: Adcal-D3

Test Group 2: Sequence CD

EXPERIMENTAL

Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) \[C\], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) \[D\], chewable tablets, orally, once, daily, on Days 15 through 28.

Drug: Calcichew D3Drug: Kalcipos-D

Test Group 2: Sequence DC

EXPERIMENTAL

Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.

Drug: Calcichew D3Drug: Kalcipos-D

Interventions

Calcichew D3DRUG

Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3)

Test Group 1: Sequence ABTest Group 1: Sequence BATest Group 2: Sequence CDTest Group 2: Sequence DC
Adcal-D3DRUG

Adcal-D3 (Calcium 600mg/400 IU Vitamin D3)

Test Group 1: Sequence ABTest Group 1: Sequence BA
Kalcipos-DDRUG

Kalcipos-D (Calcium 500mg/800 IU Vitamin D3)

Test Group 2: Sequence CDTest Group 2: Sequence DC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  • Is eligible for or currently receiving treatment with calcium and vitamin D supplement as determined by the treating clinician in accordance with local treatment guidelines.
  • Eligible participants will either be:
  • Aged 65 years or older requiring calcium and vitamin D supplementation for the prevention or treatment of deficiencies, or
  • Aged 18 years or older that require calcium and vitamin D as an adjunct to specific osteoporosis treatment in participants at risk of calcium and vitamin D deficiencies.
  • Is male or female.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study, and for 12 weeks after last dose of study medication.

You may not qualify if:

  • Has received Calcichew D3, Adcal-D3 (if the participant is in Test Group 1) or Kalcipos-D (if the participant is in Test Group 2) within the 6 months prior to the first dose of study medication.
  • Has received any investigational compound within 30 days prior to Screening.
  • Has a disease and/or condition resulting in hypercalcaemia and/or hypercalciuria and for which the study drugs are contraindicated e.g. Zollinger-Ellison syndrome, nephrolithiasis.
  • Has any of the contraindications listed in the corresponding Summary of Product Characteristics (SPC) of the study drug that the participant may receive depending on the Test Group: Calcichew D3 or Adcal-D3 (if the participant is in Test Group 1); Calcichew D3 or Kalcipos-D (if the participant is in Test Group 2).
  • Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  • Has a history of hypersensitivity or allergies to the active substances or to any of the excipients in the investigational products.
  • Has a history of known fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
  • If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bochum, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Leipzig, Germany

Location

Unknown Facility

Reading, Berkshire, United Kingdom

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Chorley, United Kingdom

Location

Unknown Facility

Liverpool, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Related Publications (1)

  • Thomasius F, Keung Nip T, Ivan P. Phase IV randomized preference study in patients eligible for calcium and vitamin D supplementation. Curr Med Res Opin. 2016 Oct;32(10):1623-1631. doi: 10.1080/03007995.2016.1202817. Epub 2016 Jun 29.

    PMID: 27322906DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Medical Director, Clinical Science
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director Clinical Science

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2015

First Posted

May 29, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 25, 2016

Results First Posted

October 25, 2016

Record last verified: 2016-08

Locations

DE(4)GB(5)