(P01-005-24) Vitamin A Absorption From Bouillon Fortified With Novel and Commercially Available Dry Vitamin A Formulations in Adult Women: Protocol for a Randomized Crossover Study

Objectives: A novel encapsulated vitamin A palmitate (VAP) formulation (PFH-VAP250-101) has improved storage and cooking stability compared to a commercially available formulation (BASF-VAP250-FG). The objective is to determine if the relative vitamin A absorption from PFH-VAP250 fortified bouillon is greater than BASF-VAP250 fortified bouillon following storage, cooking, and consumption.

Methods: Study sites in the USA and Zambia will each target 25 participants comprising healthy, nonpregnant women between 18 and 49 years old. All participants will receive three treatments (PFH-VAP250, BASF-VAP250, and positive control VAP in oil) in a randomized, blinded, crossover design. Bouillon VAP was equalized at tablet formulation, stored at 4°C for 5 months, then moved to -80°C until use. Bouillon will be prepared as broth corresponding to 1.0 mg retinol activity equivalents (RAEs) as VAP at bouillon formulation, which will decrease during storage and cooking. Broth will be consumed with a standardized meal including oil with VAP (1.0 mg RAEs) or placebo. Serial blood samples will be collected for 24 hours, and serum retinyl esters will be determined using UPLC. The (time to) maximum concentration (Tmax, Cmax) and area under the effect curve (AUEC) will be calculated from 0-8 and 0-24 hours after each treatment. AUEC and Cmax will be log-transformed, summarized as geometric and arithmetic means for each treatment, and the geometric mean ratios will determine the relative bioavailability between VAP formulations and each VAP formulation relative to positive control.

Results: In a pilot study, bouillon with PFH-VAP consumed by an adult female had a Cmax of 97.9 ng/mL at a Tmax of 5 hours. The 0-8 and 0-24 hour AUECs were 251 and 415 ng/mL*h, respectively.

Conclusions: The relative vitamin A bioavailability of bouillon fortified with different VAP formulations will be used to inform the cost-effectiveness of improved encapsulated nutrient formulations. If the improved stability through storage and cooking of PFH-VAP translates into higher VAP absorption, this could enable more effective and precise fortification strategies by improving nutrient stability while reducing the need to add excess fortificant to account for degradation.

Funding Sources: This work was supported by Particles for Humanity, PBC, with funding provided by King Philanthropies and the Mulago Foundation.