Muscle WeaknessNCT02922803
Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
A study testing 1 combination tablet of Vitamin D3/calcium per day and 2 combination tablets of Vitamin D3/calcium per day in people with Muscle Weakness and Vitamin D Deficiency, run by Uppsala University at 1 site in Sweden.
Trial summary
Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th parallel were observed to be weak and to have a waddling gate. Study 1 was carried out in the setting of an antenatal clinic administered from a primary care center in Borlänge, a Swedish middle-sized industrial town at the… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness, Vitamin D Deficiency
- What is being tested?
- 1 combination tablet of Vitamin D3/calcium per day and 2 combination tablets of Vitamin D3/calcium per day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSweden
- Study dates
- May 2010to Aug 2016
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant or new mother from Sweden or Somalia living in Borlänge and registered the antenatal clinic in Borlänge maximally 21 months prior to study start.
Who cannot join
- Severe metabolic, medical or mental disease (ex. deranged type I diabetes or psychosis).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Primary Health care center Jakobsgårdarna
Borlänge, Dalarna County, 87110
About this study
Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th parallel were observed to be weak and to have a waddling gate.
Study 1 was carried out in the setting of an antenatal clinic administered from a primary care center in Borlänge, a Swedish middle-sized industrial town at the 60:th parallel in Sweden. The investigators chose an initial study period in late spring to reflect the effects of the dark season with little ultraviolet B radiation that affects vitamin D production. Study 1 was carried out in a short period of time. The recruitment was performed in a retrospective design in order to neglect the seasonal effects of ultraviolet B radiation. Study 1 was carried out in year 2010. It was a cross sectional baseline study of blood levels of vitamin D measured as 25-hydroxyvitamin D (25-OHD) and physical performance in 123 pregnant and new mothers from Somalia (n=52) and Sweden (n=71).
Read more
Study 2: Examines the results on muscular performance, i.e. grip strength and squatting ability, from intervention with advice and prescription of vitamin D3 and calcium for 10 months, in all the women from study 1 with 25-OHD levels <50 nmol/L or 50 nmol/L of 25-OHD.
Study 3: The recruitment to Study 1 also serves as recruitment for a cohort study on delivery outcome in birth protocols starting 2016.
Study 4: The aim is to study the emic perspective and lifestyle related to vitamin D and strength in the group of Somali women by focus interviews among the Somali women from above.
A possible fifth study will explore correlations between 25-OHD and pain distribution and pain parameters.
- Conditions
- Muscle Weakness, Vitamin D Deficiency
- Being tested
- 1 combination tablet of Vitamin D3/calcium per day, 2 combination tablets of Vitamin D3/calcium per day
- Medical subject headings
- Muscle Weakness, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 combination tablet of Vitamin D3/calcium per dayDrug
Also called 1 tablet Kalcipos D Forte
Combination tablet of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
2 combination tablets of Vitamin D3/calcium per dayDrug
Also called 2 tablets Kalcipos D Forte
Combination tablets of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D insufficient | Active comparator | Subjects with Vitamin D level in blood > 25 nmool/L < 50 nmol/L will be treated with 1 combination tablet of Vitamin D3/calcium per day Receives: Drug: 1 combination tablet of Vitamin D3/calcium per day |
| Vitamin D deficient | Active comparator | Subjects with Vitamin D level in blood < 25 nmol/L (25-OHD) will be treated with 2 combination tablets of Vitamin D3/calcium per day Receives: Drug: 2 combination tablets of Vitamin D3/calcium per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-25-hydroxyvitamin D in nmol/L.
Measured: 10 months
Grip strength in Newton.
Measured: 10 months
Upper leg strength, able or not able to squat
Measured: 10 months
Secondary outcomes (3)
Trendelenburg's sign positive or not. not.
Measured: 10 months
Sit to stand five times, able or not.
Measured: 10 months
Standing on one leg 30 seconds, able or not
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startMay 2010
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Kalliokoski, Uppsala University
- Investigators
- Paul Kalliokoski, MD, Principal investigator, Uppsala UniversityMonica Löfvander, Ass. Prof., Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922803
- Sponsor's protocol ID
- DVITOS2
- Status last verified
- Sep 2016
- First submitted
- 28 Sep 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kalliokoski P, Bergqvist Y, Lofvander M. Physical performance and 25-hydroxyvitamin D: a cross-sectional study of pregnant Swedish and Somali immigrant women and new mothers. BMC Pregnancy Childbirth. 2013 Dec 17;13:237. doi: 10.1186/1471-2393-13-237.
PubMed 24345271Torstensson T, Kristiansson P, Kalliokoski P. Biochemical osteomalacia during pregnancy or lactation: an observational study in Sweden. BMC Pregnancy Childbirth. 2026 Feb 24;26(1):220. doi: 10.1186/s12884-026-08848-1.
PubMed 41735914Kalliokoski P, Widarsson M, Rodhe N, Lofvander M. Positive impact on vitamin D related lifestyle of medical advice in pregnant Somali-born women and new mothers: a mixed method study in Swedish primary care. BMC Public Health. 2021 Feb 5;21(1):297. doi: 10.1186/s12889-021-10277-y.
PubMed 33546641Kalliokoski P, Rodhe N, Bergqvist Y, Lofvander M. Long-term adherence and effects on grip strength and upper leg performance of prescribed supplemental vitamin D in pregnant and recently pregnant women of Somali and Swedish birth with 25-hydroxyvitamin D deficiency: a before-and-after treatment study. BMC Pregnancy Childbirth. 2016 Nov 15;16(1):353. doi: 10.1186/s12884-016-1117-3.
PubMed 27846821
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
- ClinicalTrials.gov ID
- NCT02922803
- Acronym / sponsor ID
- DVITOS2
- Conditions
- Muscle Weakness, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Oct 2016 (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.
Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th parallel were observed to be weak and to have a waddling gate.
Study 1 was carried out in the setting of an antenatal clinic administered from a primary care center in Borlänge, a Swedish middle-sized industrial town at the 60:th parallel in Sweden. The investigators chose an initial study period in late spring to reflect the effects of the dark season with little ultraviolet B radiation that affects vitamin D production. Study 1 was carried out in a short period of time. The recruitment was performed in a retrospective design in order to neglect the seasonal effects of ultraviolet B radiation. Study 1 was carried out in year 2010. It was a cross sectional baseline study of blood levels of vitamin D measured as 25-hydroxyvitamin D (25-OHD) and physical performance in 123 pregnant and new mothers from Somalia (n=52) and Sweden (n=71).
Study 2: Examines the results on muscular performance, i.e. grip strength and squatting ability, from intervention with advice and prescription of vitamin D3 and calcium for 10 months, in all the women from study 1 with 25-OHD levels <50 nmol/L or 50 nmol/L of 25-OHD.
Study 3: The recruitment to Study 1 also serves as recruitment for a cohort study on delivery outcome in birth protocols starting 2016.
Study 4: The aim is to study the emic perspective and lifestyle related to vitamin D and strength in the group of Somali women by focus interviews among the Somali women from above.
A possible fifth study will explore correlations between 25-OHD and pain distribution and pain parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D insufficient | Active comparator | Drug: 1 combination tablet of Vitamin D3/calcium per daySubjects with Vitamin D level in blood > 25 nmool/L < 50 nmol/L will be treated with 1 combination tablet of Vitamin D3/calcium per day |
| Vitamin D deficient | Active comparator | Drug: 2 combination tablets of Vitamin D3/calcium per daySubjects with Vitamin D level in blood < 25 nmol/L (25-OHD) will be treated with 2 combination tablets of Vitamin D3/calcium per day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant or new mother from Sweden or Somalia living in Borlänge and registered the antenatal clinic in Borlänge maximally 21 months prior to study start.
Key exclusion criteria (1 listed)
- Severe metabolic, medical or mental disease (ex. deranged type I diabetes or psychosis).
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 |
|---|---|---|
| 1 combination tablet of Vitamin D3/calcium per dayAlso: 1 tablet Kalcipos D ForteCombination tablet of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg) | Drug | Vitamin D insufficient |
| 2 combination tablets of Vitamin D3/calcium per dayAlso: 2 tablets Kalcipos D ForteCombination tablets of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg) | Drug | Vitamin D deficient |
Primary outcome
S-25-hydroxyvitamin D in nmol/L.
Time frame: 10 months
Grip strength in Newton.
Time frame: 10 months
Upper leg strength, able or not able to squat
Time frame: 10 months
3 secondary outcomes
Trendelenburg's sign positive or not. not.
Time frame: 10 months
Sit to stand five times, able or not.
Time frame: 10 months
Standing on one leg 30 seconds, able or not
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Results publication: PubMed 24345271Kalliokoski P, Bergqvist Y, Lofvander M. Physical performance and 25-hydroxyvitamin D: a cross-sectional study of pregnant Swedish and Somali immigrant women and new mothers. BMC Pregnancy Childbirth. 2013 Dec 17;13:237. doi: 10.1186/1471-2393-13-237.
- Derived from this study: PubMed 41735914Torstensson T, Kristiansson P, Kalliokoski P. Biochemical osteomalacia during pregnancy or lactation: an observational study in Sweden. BMC Pregnancy Childbirth. 2026 Feb 24;26(1):220. doi: 10.1186/s12884-026-08848-1.
- Derived from this study: PubMed 33546641Kalliokoski P, Widarsson M, Rodhe N, Lofvander M. Positive impact on vitamin D related lifestyle of medical advice in pregnant Somali-born women and new mothers: a mixed method study in Swedish primary care. BMC Public Health. 2021 Feb 5;21(1):297. doi: 10.1186/s12889-021-10277-y.
- Derived from this study: PubMed 27846821Kalliokoski P, Rodhe N, Bergqvist Y, Lofvander M. Long-term adherence and effects on grip strength and upper leg performance of prescribed supplemental vitamin D in pregnant and recently pregnant women of Somali and Swedish birth with 25-hydroxyvitamin D deficiency: a before-and-after treatment study. BMC Pregnancy Childbirth. 2016 Nov 15;16(1):353. doi: 10.1186/s12884-016-1117-3.
- Individual participant dataSharing planned: No
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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.
Paul Kalliokoski, MD principal investigator
Uppsala University
Monica Löfvander, Ass. Prof. study director
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 combination tablet of Vitamin D3/calcium per day and 2 combination tablets of Vitamin D3/calcium per day in people with Muscle Weakness and Vitamin D Deficiency, run by Uppsala University at 1 site in Sweden.
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: finished, as of the sponsor's last update on 4 Oct 2016. 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 Sweden. 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?
S-25-hydroxyvitamin D in nmol/L. (time frame: 10 months). The study lists 3 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 NCT02922803, which also lists 4 linked publications.
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 4 Oct 2016.