Does Vitamin D Alter Bone's Response to Vibration?

NCT02743559 | Withdrawn DMC

• 1 other identifier: SCH/15/094
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Fractures in children are common and the incidence is increasing. They are more common in children who have small, narrow and weak bones. Studies have shown that fractures in early childhood are associated with later bone strength. There are several (i) non-modifiable (age, gender, race, genetics) and (ii) modifiable factors such as nutrition (vitamin D \& calcium intake) and exercise that can contribute to bone strength. Low calcium is associated with an increased risk of fracture. Vitamin D plays a pivotal role in bone health by increasing the absorption of calcium from the gut. Investigators know from the previous research that there is a reduction in bone strength in children whose mothers had lower vitamin D levels during pregnancy. Bone growth can also be achieved by loading of bone during childhood in the form of regular sport activities such as gymnastics and exercise programmes. Equally it can be achieved by using whole body vibration (WBV). WBV is the application of vibratory stimulus to the body in a synchronous fashion by which the bones are made much stronger reducing the risk of fracture in later life. Thus WBV can be used as a means to assess bone responsiveness to mechanical stimulation. Studies have shown that standing on a vibrating platform for 10 minutes a day can significantly increase the bone mass. Investigators' own research has also shown that healthy boys when made to stand on a vibration platform for 10 minutes daily for 5 days increased the strength and quality of their bones. Thus the role of diet and mechanical loading are of considerable interest in determining their role in bone health and the prevention of fractures. Maternal Vitamin D Osteoporosis Study (MAVIDOS) is a large study conducted recently at 3 different big centres (Sheffield, Southampton and Oxford). Results from this study have shown that giving a higher dose of vitamin D to pregnant women every day from 14 weeks of pregnancy increased the strength of the bones in their infants. In the proposed study Investigators aim to show how vitamin D supplementation during pregnancy affects the response of bone to vibration in children whose mothers participated in the MAVIDOS study in Sheffield. These children will be 4 years of age when they participate in this study. The results of this study will help inform public health policy on vitamin D intake during pregnancy. This will also help the investigators identify a possible risk factor for poor bone health in children.

Conditions

Vitamin D Deficiency; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Difference in mean increase in the bone turnover marker Pro-collagen type 1 N-terminal propeptide (P1NP) between children born to antenatally vitamin D replete mothers versus antenatally vitamin D deficient mothers.

  2 years

Secondary Outcomes (3)

• Change in C-terminal cross-linked telopeptide of type I collagen(CTx)

  2 years

• Change in Osteoprotegerin(OPG).

  2 years

• Change in parathyroid hormone (PTH).

  2 years

Study Arms (2)

Vitamin D group

ACTIVE COMPARATOR

Children born to mothers who received vitamin D during pregnancy will undergo mechanical stimulation using whole body vibration(WBV) by standing on the vibration platform(LivMd) for 10 minutes on 5 consecutive mornings, at 7.30-8 am.

Device: Mechanical Stimulation using whole body vibration

Placebo group

PLACEBO COMPARATOR

Children born to mothers who received placebo during pregnancy will also undergo mechanical stimulation using whole body vibration(WBV) by standing on the vibration platform (LivMd) for 10 minutes on 5 consecutive mornings, at 7.30-8 am.

Device: Mechanical Stimulation using whole body vibration

Interventions

Mechanical Stimulation using whole body vibration DEVICE

All participants will undergo whole body vibration (WBV) by standing on the LivMD WBV platform on 5 consecutive mornings

Placebo group; Vitamin D group

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children born to mothers who participated in MAVIDOS trial in Sheffield free from any condition affecting bone health, general nutrition, growth and glucose metabolism will be invited to enrol in the study.

You may not qualify if:

• Children with (1) balance problems, (2) current or healing fractures (3) any chronic illness involving the bone, liver and kidney (4) current long-term use of steroids, anticonvulsants or any medication that might affect calcium and vitamin D metabolism will be identified from through a questionnaire and excluded.
• Participants will fill in questionnaires to estimate their calcium intake and Vitamin D exposure and this will be included in the analysis

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead
• University of Sheffield: collaborator
• University of Southampton: collaborator
• University of Hull: collaborator

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Osteoporosis

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases

Study Officials

• Sujatha Gopal

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 19, 2016
• Study Start: May 19, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

GB (1)