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NCT07928180

Oral B-Complex Vitamin (B6, B9 and B12) Prevents Low Anterior Resection Syndrome in Rectal Cancer Patients With Hyperhomocysteinemia

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 277 → 134 participants
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints: 7 to 6
    • Study description shortened, about 1 word
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence of Low Anterior Resection Syndrome (LARS)
Timeframe: 6 months after surgery (3 months after stoma closure for participants whose protective stoma has not been closed by 6 months after surgery)

Secondary (6)

LARS Score
Serum Homocysteine Concentration
Anal Resting Pressure
Maximum Anal Squeeze Pressure
Presence of Rectoanal Inhibitory Reflex
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profiling of microbiome

Arms and interventions

Oral B-Complex Vitamin (B6, B9 and B12)Experimental

Participants will take Oral B-Complex Vitamin (B6, B9 and B12) tablets, 2 tablets orally per day, starting after resumption of oral intake following surgery. Serum homocysteine (Hcy) will be measured at 3 and 6 months after surgery.

PlaceboPlacebo comparator

Participants will take placebo tablets identical in appearance, color, odor and packaging to the Oral B-Complex Vitamin (B6, B9 and B12) tablets, 2 tablets orally per day, starting after resumption of oral intake following surgery. Treatment will continue until the 6-month postoperative visit.

Dietary supplements: Oral B-Complex Vitamin (B6, B9 and B12)

Other: Placebo

Sites

1 site in 1 country

  • Qilu Hospital of Shandong UniversityJinan, Shandong, China