Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition (ViDiSAM)

  • STATUS
    Recruiting
  • End date
    Oct 21, 2023
  • participants needed
    250
  • sponsor
    Queen Mary University of London
Updated on 21 March 2022

Summary

This double-blind randomized placebo-controlled controlled trial will test the hypothesis that administration of high-dose oral vitamin D supplementation to children in Lahore, Pakistan, who are recovering from complicated severe acute malnutrition will safely accelerate weight gain (primary outcome) and enhance neurodevelopment, muscle mass accumulation, resolution of systemic inflammation and antimicrobial immune function (secondary outcomes).

Details
Condition Severe Acute Malnutrition
Treatment Placebo, Vitamin D3
Clinical Study IdentifierNCT04270643
SponsorQueen Mary University of London
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Consent of parent / guardian
Age 6-59 months at enrolment
Diagnosis of complicated SAM at the point of hospital admission as defined by the World Health Organisation
Medical team managing the child has made the decision to discharge the child from inpatient care

Exclusion Criteria

Ingestion of a dose of vitamin D>200,000 IU (5 mg) in the last 3 months
Known diagnosis of primary hyperparathyroidism or sarcoidosis (i.e. conditions pre-disposing to vitamin D hypersensitivity)
Known neurodevelopmental disorder (e.g. cerebral palsy)
HIV infection
Taking anti-tuberculosis treatment
Inability to assess child's developmental status at baseline using the Malawi Development Assessment Tool
Signs of rickets
Corrected serum calcium concentration >2.65 mmol/L on blood sample taken during the current hospital admission
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note