Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/06/2018
Date assigned
04/07/2018
Last edited
23/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mahmut Apaydin

ORCID ID

Contact details

Diskapi Training and Research Hospital
Ankara
06110
Turkey
0905052349090
drmahmutapaydin@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19/36

Study information

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

Acronym

Study hypothesis

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

Medical Ethics Committee of Ankara Diskapi Training and Research Hospital, 26/01/2015, ref: 19/36

Study design

Non-randomised parallel-arm study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

01/11/2014

Overall trial end date

01/02/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy
2. Postmenopausal
3. Aged 50-68 years
4. Vitamin D level <20 ng/ml (50 nmol/l)

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

60

Participant 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

Recruitment start date

15/02/2015

Recruitment end date

15/10/2015

Locations

Countries of recruitment

Turkey

Trial participating centre

Diskapi Training and Research Hospital
İrfan Bastug Cad. 06110, Altındag/ Ankara, Turkey
Ankara
06110
Turkey

Sponsor information

Organisation

Diskapi Training and Research Hospital

Sponsor details

-
Ankara
06110
Turkey
0903125962000
info@diskapieah.gov.tr

Sponsor type

Hospital/treatment centre

Website

http://www.diskapieah.gov.tr/diskapi1/

Funders

Funder type

Not defined

Funder name

None

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are planning to publish it in BMC Endocrine Disorders

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request from Dr Mahmut Apaydin.

Intention to publish date

01/12/2018

Participant level data

Available on request

Basic results (scientific)

Pretreatment vitamin D levels did not differ between the two groups (10.2±4.4 ng/mL (25,4±10,9 nmol/L); 9.7±4.4 ng/mL (24,2±10,9 nmol/L), p>0.05). A significant increase in vitamin D levels was observed in both groups at 4 and 12 weeks after vitamin D3 treatment. The increase in the single-dose group was significantly higher than the daily low-dosage group at the 4th week (35.9±9.6 ng/mL (89,6±23,9 nmol/L), 16.9±5.8 ng/mL (42,1±14,4 nmol/L), p=0.01). The increase in the single-dose group was significantly higher than in the daily low dosage group at the 12th week (23.4±4.7 ng/mL (58,4±11,7 nmol/L), 19.8±7.2 ng/mL (49,4±17,9 nmol/L), p=0.049). The quadriceps muscle strength score increased significantly in the daily group at the 4th week (p=0.038). The hamstring muscle strength score increased significantly in the daily group at the 12th week (p=0.037).

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30031389

Publication citations

Additional files

Editorial Notes

23/07/2018: Publication reference added.