Effect of single high-dose or daily low-dose vitamin D on muscle strength in older women
| ISRCTN | ISRCTN14226530 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14226530 |
| Secondary identifying numbers | 19/36 |
- Submission date
- 24/06/2018
- Registration date
- 04/07/2018
- Last edited
- 23/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Vitamin D deficiency is a public health problem. There are many consequences of vitamin D deficiency. Many studies have investigated the effects of vitamin D supplementation on muscle strength, but the results remain controversial. There is also contradictory data about which administration route is healthier. We aimed to compare the effects and safety of single high-dose with daily low-dose oral colecalciferol on 25(OH)D levels and muscle strength in postmenopausal women with vitamin D deficiency or insufficiency.
Background and study aims
Vitamin D is involved in calcium absorption, immune function and protecting bone, muscle and heart health. Vitamin D deficiency is a common health problem. Vitamin D supplements are used to improve vitamin D status; however, there is contradictory information on what doses to give and how often they should be given. Many studies have investigated the effects of vitamin D supplementation on muscle strength, but the results remain controversial. We aimed to compare the effects and safety of a single high dose with daily low doses of oral colecalciferol (vitamin D3) on vitamin D levels and muscle strength in postmenopausal women with vitamin D deficiency or insufficiency.
Who can participate?
Postmenopausal women who had low vitamin D levels in their blood
What does the study involve?
One group received a low dose of vitamin D3 once a day by mouth and the second group received a single high dose of vitamin D3 by mouth. Blood vitamin D levels and muscle strengths were measured at before the women took the vitamin D3 and at the 4th and 12th weeks.
What are the possible benefits and risks of participating?
Participants will receive treatment for their vitamin D deficiency. Side effects from vitamin D supplements are not common and occur almost exclusively in people who take long-term, high-dose supplements without monitoring blood levels. Elevated calcium levels, nausea, vomiting, poor appetite, stomach pain, constipation or diarrhea, kidney injury are potential side effects of excessive vitamin D intake.
Where is the study run from?
The Endocrinology and Metabolism Clinic of Ankara Diskapi Training and Research Hospital
When is the study starting and how long is it expected to run for?
November 2014 to February 2016
Who is funding the study?
There is no funding source for the study. The study coordinators will cover all expenses and participants will not be responsible for any expenses.
Who is the main contact?
Dr Mahmut Apaydin, drmahmutapaydin@gmail.com
Contact information
Scientific
Diskapi Training and Research Hospital
Ankara
06110
Türkiye
| Phone | 0905052349090 |
|---|---|
| drmahmutapaydin@gmail.com |
Study information
| Study design | Non-randomised parallel-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effects of single high-dose or daily low-dosage oral colecalciferol treatment on vitamin D levels and muscle strength in postmenopausal women |
| Study objectives | Many studies have investigated the effects of vitamin D supplementation on muscle strength, but the results remain controversial. We aimed to compare the effects and safety of single high-dose with daily low-dose oral colecalciferol on 25(OH)D levels and muscle strength in postmenopausal women with vitamin D deficiency or insufficiency |
| Ethics approval(s) | Medical Ethics Committee of Ankara Diskapi Training and Research Hospital, 26/01/2015, ref: 19/36 |
| Health condition(s) or problem(s) studied | Effect on muscle strength of vitamin D supplementation |
| Intervention | 60 healthy postmenopausal women who had serum vitamin D levels <20 ng/ml (50 nmol/l) were enrolled in the study. Group 1 (n=32) was given daily oral dosages of 800 IU vitamin D3, and group 2 (n=28) was given a single oral dose of 300,000 IU vitamin D3. Serum vitamin D levels and muscle strengths were measured at baseline, week 4 and week 12. |
| Intervention type | Supplement |
| Primary outcome measure | 25OH vitamin D levels 3 months after treatment |
| Secondary outcome measures | Muscle strength 3 months after treatment. Muscle strength tests were performed at 60° using a Biodex system 3 isokinetic dynamometer. |
| Overall study start date | 01/11/2014 |
| Completion date | 01/02/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Healthy 2. Postmenopausal 3. Aged 50-68 years 4. Vitamin D level <20 ng/ml (50 nmol/l) |
| Key exclusion criteria | 1. Individuals who had granulomatous conditions, thyroid disease, malabsorption syndromes, liver disease, kidney disease, diabetes or postural instability (cerebellar disease, vestibular disease, vitamin B12 deficiency, drugs) 2. Individuals taking anticonvulsants, calcium or vitamin D supplements, barbiturates, or steroids in any form |
| Date of first enrolment | 15/02/2015 |
| Date of final enrolment | 15/10/2015 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Ankara
06110
Türkiye
Sponsor information
Hospital/treatment centre
-
Ankara
06110
Türkiye
| Phone | 0903125962000 |
|---|---|
| info@diskapieah.gov.tr | |
| Website | http://www.diskapieah.gov.tr/diskapi1/ |
"ROR" |
https://ror.org/04bghze60 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We are planning to publish it in BMC Endocrine Disorders |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Mahmut Apaydin. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/07/2018 | Yes | No |
Editorial Notes
23/07/2018: Publication reference added.
