NCT04217564: AlAiny

Nutritional Counselling for Patients at Kasr AlAiny Multiple Sclerosis Clinic: an Intervention Study

Completed NA Last updated 22 July 2020

What this trial tests

NA trial testing Nutritional counselling in Multiple Sclerosis in 120 participants. Completed in 30 June 2020.

Timeline

1 January 2020

Primary endpoint
18 March 2020

30 June 2020

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	120
Start date	1 January 2020
Primary completion	18 March 2020
Estimated completion	30 June 2020
Sites	1 location across Egypt

Drugs / interventions tested

• Nutritional counselling

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Cairo University

Who can join

Adults 20 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Eligible Multiple sclerosis patients attending Kasr AlAiny Multiple Sclerosis Clinic will be randomly allocated to either the intervention or control group by randomized block design.

Patients in the 2 groups will be initially assessed. Those in the intervention group will receive a counselling session then instructed on the subsequent follow up dates. Those in the control group will not receive nutritional counselling during the study period but will be instructed to attend for final assessment by the end of the study. Apart from counselling, patients will receive the same care from the clinic medical staff. After the final assessment the control group will be invited to receive the nutritional counselling material to gain its suspected benefits.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults.
   Baldwin C, de van der Schueren MA, Kruizenga HM, Weekes CE. · · 2021 · cited 24× · PMID 34931696 · DOI 10.1002/14651858.cd002008.pub5
2. Impact of nutrition counseling on anthropometry and dietary intake of multiple sclerosis patients at Kasr Alainy Multiple Sclerosis Unit, Cairo, Egypt 2019-2020: randomized controlled clinical trial.
   Afifi Z, Hassan A, Abdelrahman N, El Sayed A, et al · · 2023 · cited 8× · PMID 36691061 · DOI 10.1186/s13690-022-01013-y
3. Impact of Nutrition Counselling on Multiple Sclerosis Patients Nutritional Status: Randomized Controlled Clinical Trial
   Afifi Z, Hassan A, Abdelrahman N, Sayed AE, et al · · 2022 · DOI 10.21203/rs.3.rs-1425231/v1